Sotorasib fda label. Physician Labeling; PMA Database Entry .

Sotorasib fda label Sotorasib blocked KRAS signaling, inhibited cell growth, and promoted apoptosis only in KRAS G12C tumor cell lines. Sotorasib is approved to treat: non-small cell lung cancer (NSCLC) that has spread and has a KRAS p. 14-19 This labeling strategy is coun-terintuitive and is not consistent with labeling of non-oncology oral drugs, which are usually labeled with food if there is a large positive food effect. Patient Selection What is LUMAKRAS ®?. The label provides information on dosage, administration, warnings, adverse reactions, drug interactions, and more. 3. Jan 17, 2024 · For non-prescription products, read the label or package ingredients carefully. to tolerability. It also holds a breakthrough therapy designation in the US and China. Warnings and Precautions (5. 9% Sodium Chloride Injection, USP is Jun 1, 2021 · On May 28, 2021, the U. It is the first FDA-approved highly selective KRAS inhibitor proven to successfully target KRAS G12C, once deemed an undruggable target. Co-administered Drug Aug 1, 2024 · Drugging KRAS in cancer has been a long and painful exercise in medicinal chemistry and clinical trial design and delivery. The presented study aimed to evaluate sotorasib-associated AEs using the FDA Adverse Event Reporting System (FAERS Dec 26, 2023 · --Amgen announced today that the U. CodeBreaK 300 is a multicenter, open-label, D. Under fed conditions (standard-calorie moderate-fat meals), co-administration of multiple doses of omeprazole with a single dose of 960 mg sotorasib decreased sotorasib C max by 65% and AUC by 57%. and is known as ‘ Dec 21, 2022 · The Food and Drug Administration recently granted accelerated approval to sotorasib for the treatment of patients with KRAS p. Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for CodeBreaK 100 is an ongoing, multicentre, noncomparative, open-label, single-group phase I/II study. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. 0 mg orally twice a week for 21 of 28 days and oral sotorasib 960 mg twice a day for all 28 days was selected as the recommended phase 2 dose (RP2D) based on dose limiting toxicity assessment. S. 1 Pregnancy . Sotorasib forms an irreversible, covalent bond with the unique cysteine of KRAS G12C, locking the protein in an inactive state that prevents downstream signalling without affecting wild-type KRAS. Dosage Modifications for Adverse Reactions 2. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma . Take it as directed on the prescription label at the same time every day. Persistent ulcerative keratitis [see . 2 of 16 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test [see Dosage Mar 10, 2024 · Not known whether sotorasib or its metabolites distribute into human milk or if the drug has any effect on milk production or the breast-fed infant. 26, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that the U. Last updated on Dec 19, 2024. , Aug. Your doctor will perform tests to make sure sotorasib is the right treatment for you. The change is in the gene . Amgen, Inc. 7% (all grades) and 1. 1 Content of labeling must be identical to the enclosed labeling (text for the Prescribing Information), with the addition of any labeling changes in pending “Changes Abstract. 1. 16, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U. The approval was based on CodeBreaK 100 (Study 20170543), a dose-escalation and dose-expansion trial in Jan 2, 2024 · The FDA has rejected the supplemental new drug application (sNDA) for sotorasib (Lumakras) for patients with previously treated locally advanced or metastatic KRAS G12C-mutated non–small cell lung cancer (NSCLC). Treatment exceeds the maximum limit of 240 (120 mg) or 90 (320 mg) tablets/month. A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. 20 This increased bio- Apr 14, 2022 · On May 28, 2021, the FDA granted accelerated approval to sotorasib (Lumakras, Amgen) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy. You may also report side effects to Amgen at 1-800-772-6436 (1-800-77-AMGEN). Do not cut, crush, or chew this medication. If it upsets your stomach, take it with food. Table 1 [see Drug Interactions (7. Food and Drug Administration has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS ®. Investigational use of Lumakras (sotorasib) with an off-label indication that is not sufficient in evidence or is not generally accepted by the medical community. Revised:12/2020 FULL PRESCRIBINGINFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1. The efficacy of sotorasib was demonstrated through patient enrollment in Amgen’s CodeBreaK 100, a single-arm, open-label, multicenter clinical trial (n= 357; 124 LUMAKRAS® (sotorasib) product fact sheet Storage and handling Store at 20 ⁰C to 25 C (68 F to 77⁰F). Oct 30, 2024 · The FDA extended the PDUFA date for sotorasib/panitumumab in KRAS G12C-mutated mCRC to January 17, 2025, for additional data review. The FDA has approved the first KRAS-targeted therapy, sotorasib, for patients with previously treated non-small cell lung cancer with KRASG12C mutations. FDA label information for this drug is available at DailyMed. This study aims to compare their efficacy in treating KRAS G12C-mutated NSCLC, drawing insights from pivotal FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) 1 (1. In a phase II trial, the drug yielded a median progression-free survival of 6. About Advanced Sep 23, 2024 · Yes, Lumakras has an orphan drug designation from the FDA for KRAS G12C-positive NSCLC and colorectal cancer. Revised: 9/2021 . 2023; 401: 733–46. Jan 19, 2024 · There were no drug-drug interactions observed between the combination of avutometinib and sotorasib, and avutometinib 4. 1)]. LUMAKRAS ® is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery, and whose tumor has an abnormal KRAS G12C gene, and who have received at least one prior treatment for their cancer. (sotorasib) tablets, for oral use FDA-approved patient labeling. Mar 4, 2023 · We randomly assigned (1:1) patients to oral sotorasib (960 mg once daily) or intravenous docetaxel (75 mg/m 2 once every 3 weeks) in an open-label manner using interactive response technology. Drug Name/Dosage Form Sotorasib / Tablet Strength 120 mg Route of Administration Oral Rx/OTC Dispensed Rx Dec 11, 2024 · Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. 5. MEKINIST ® is indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with Sep 20, 2021 · In contrast to the DDI summary, which is mainly based on the NDA review at the time of the drug approval, Drug Characteristics are identified based on the most up-to-date information from the literature and/or drug labels, and may change when new information becomes available. G12C Dec 19, 2024 · Package insert / product label Generic name: sotorasib Dosage form: tablet, coated Drug class: Miscellaneous antineoplastics Medically reviewed by Drugs. 2 Dec 16, 2020 · THOUSAND OAKS, Calif. Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras™), a RAS GTPase family inhibitor, for adult patients with KRAS G12Cmutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. KRAS. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic a If no recovery after 30 day interruption, treatment will be discontinued unless the patient is deriving clinical benefit . See full prescribing information for LUMAKRAS. 1 . In this study 3 2. ILD or pneumonitis is mentioned in the drug label for both sotorasib and adagrasib [20], [21]. 1 • endometrial cancer, as determined by an FDA -approved test, that has progressed on or following prior treatment with a platinum-containing regimen, or • solid tumors, as determined by an FDA -approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. 1) Colorectal cancer (CRC)* In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment Sotorasib forms an irreversible, covalent bond with the unique cysteine of KRAS G12C, locking the protein in an inactive state that prevents downstream signaling without affecting wild-type KRAS. DrugBank Sotorasib is a small molecule inhibitor of the KRAS G12C mutant protein which is found in up to 13% of refractory cases of non-small cell lung cancer. G12C-mutated locally advanced or metastatic content of labeling [21 CFR 314. Drug Product Expiration Dating Period: 24 months shelf-life, store at 20 C to 25 C, excursions permitted 15 C to 30 C. Sep 20, 2021 · drug approvals in which the labeled prandial conditions (eg, avoidance of food in conjunction with administration) minimize absorption. Jan 2, 2024 · The FDA issued a complete response letter to a supplemental new drug application (sNDA) seeking the full approval of sotorasib (Lumakras) as a treatment for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring a KRAS G12C mutation, according to a press release from Amgen. LUMAKRAS ® (sotorasib) tablets, for oral use Initial U. com. 1 Patient Selection . See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. This label may not be the latest approved by FDA. Monitor and manage patients using supportive care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Sotorasib is a highly selective inhibitor of KRAS G12C that suppresses the rapid proliferation of cancer cells. Sotorasib is a new molecular entity and was 4071-4 Conduct a clinical drug interaction study to assess the effect of concomitant sotorasib administration on the systemic exposure of BCRP transporter substrates. b If more than 2 dose reductions are required, treatment will be discontinued Dosage Modifications for Drug Interactions Recommended dose modifications of BRUKINSA for drug interactions are provided in . 4 . Lancet. 11 A second real-world study reported that 15 of 53 (28%) patients with CPI exposure within 12 weeks of initiation of sotorasib . It is approved under FDA’s Accelerated Approval Program and has a collection of links to more information, research results, and clinical trials. Food and Drug Administration (FDA) for sotorasib, an investigational KRAS G12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test Oct 5, 2023 · In this open-label trial, it is possible that emerging data . You can take it with or without food. KRAS . Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras™, Amgen) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy. This blocks the protein from acting, interrupting the chemical messages the cancer cells need for growing and spreading, and it also encourages processes that cause the cancer cells to die. 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS On May 28, 2021, the Food and Drug Administration granted accelerated approval to sotorasib (Lumakras™, Amgen, Inc. Recommended Dosage and Administration 2. In this experiment, researchers recruited 124 advanced NSCLC patients with KRAS G12C-mutation, 96 % of the participants had received at least two or more therapies including chemotherapy and immunotherapy. G12C mutation. Refer to FDA Guidance for Industry for additional details: “ Clinical Drug Interaction Studies - Cytochrome P450 Enzyme and Transporter- Mediated Drug Interactions. Inspect vial contents for particulate matter and discoloration prior to dilution [see Description (11)]. FDA approval summary: sotorasib for KRAS G12C-mutated metastatic NSCLC. 4 Preparation for Administration . USE IN SPECIFIC POPULATIONS . 8. Apr 5, 2024 · Data from one real-world study found that of 19 patients who initiated sotorasib within 30 days of prior CPI (40% of all patients in this cohort), 11 (58%) patients experienced grade ≥3 hepatotoxicity on sotorasib. Use in Cancer. epkinly. , May 28, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U. Revised: 01/2023 . Nevertheless, the FDA review team highlighted concerns about the reliability of the results, given its scale compared to the frequency of imaging assessments (5 weeks versus 6 weeks) and the discordance between investigators and BICR, which indicated the existence of bias. fda. , Dec. (“Applicant”) conducted CodeBreaK 200, an open-label clinical trial, which randomized patients NDA/BLA Multi-disciplinary Review and Evaluation {NDA 214665} LUMAKRAS™ (sotorasib) 2 Version date: January 2020 (ALL NDA/ BLA reviews) Disclaimer: In this document, the sections labeled as “Data” and “The Applicant’s Position” are completed by the May 28, 2021 · THOUSAND OAKS, Calif. org On May 28, 2021, FDA granted accelerated approval to sotorasib (brand name Lumakras), Efficacy was demonstrated in CBGJ398X2204, a multicenter open-label single-arm trial, that enrolled 108 Sotorasib is a targeted therapy for non-small cell lung cancer with a KRAS p. seeks approval for sotorasib for the treatment of patients with KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy. Oct 7, 2024 · The May 2021 accelerated approval of sotorasib 960 mg once daily, for KRAS-mutated advanced lung cancer, was accompanied by a postmarketing requirement (PMR) to conduct a randomized trial comparing the approved 960 mg dosage with 240 mg once daily. 50(l)] in structured product labeling (SPL) format using the FDA automated drug registration and listing system (eLIST), as described at FDA. To view updated drug label links, paste May 15, 2024 · FDA's accelerated approval of sotorasib for marketing is based on the results of a Phase I/II clinical study codenamed CodeBreaK 100 [5]. 5)] Dose Modifications for Drug Interactions . 05 October 2023 ODAC Meeting Briefing Document Sotorasib was granted FDA approval on May 28, 2021, followed by the European Commission's approval on January 10, 2022. Yet, docetaxel with ramucirumab had already shown a 1·5 Sotorasib has been approved for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). PubMed. Dosing exceeds single dose limit of Lumakras (sotorasib) 960 mg. BACKGROUND . FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION Patient Selection FDA Has Issued New Postmarketing Requirement. LUMAKRAS (sotorasib) tablets, for oral use Initial U. 9-11 As another example, nindetanib Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. We have brought the sotorasib new drug application (NDA) 214665 supplement Amgen Inc. 3 Females and Males of Reproductive Potential . Because of its known toxicity, drugs that inhibit CYP 3A4 activity should be avoided or the dose of sotorasib adjusted according. NDA 214665, Sotorasib II. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. 1 The drug's accelerated approval status remains in place. G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved associated with sotorasib listed below are currently included in the draft labeling 5 Section 5 Warnings and Precautions. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced submission of a New Drug Application (NDA) to the U. How should I store LUMAKRAS? Store LUMAKRAS at room temperature between 68°F to 77°F (20°C to 25°C). The approval was bas … CodeBreaK 100 was a single-arm, open-label, global, multicenter clinical trial with the Phase 2 portion evaluating LUMAKRAS ®  (sotorasib) in 126 patients with locally advanced or metastatic KRAS G12C–mutated NSCLC who progressed on prior therapy. 2 Recommended Dose and Dosage Adjustment 10 / 2023 4. In CodeBreaK 100 study, hepatotoxicity occurred in 1. (1, 2. Excursions permitted from 15 ⁰C to 30 C (59⁰F to 86 F) [see USP Controlled Room Temperature] Supplied and marketed by Amgen USA Inc. , two-part multicenter, parallel cohort, randomized, open-label Phase 2 registration May 7, 2024 · The FDA told Amgen to test whether a quarter-dose of sotorasib worked as well as the amount on the label. This Prior Approval sNDA provides for registration of a 320 mg strength Lumakras (sotorasib) tablet, in addition to the currently approved 120 mg strength tablet, and addition of an alternate site for release and stability testing. In the CodeBreaK 200 study, PFS evaluated by BICR served as the primary endpoint. 1 ; Interstitial Lung Disease/Pneumonitis : Severe, life-threatening, and fatal interstitial lung disease (ILD)/pneumonitis can occur in FDA-approved test, who have received at least one prior systemic therapy. Sotorasib, also known as AMG-510, is an acrylamide-derived KRAS inhibitor developed by Amgen. THOUSAND OAKS, Calif. LUMAKRAS is an oral inhibitor of KRAS G12C-mutated NSCLC for patients who have received prior systemic therapy. 4 Administration 10 / 2023 7 WARNINGS AND PRECAUTIONS 08 / 2024 Sep 20, 2021 · The FDA requirement to optimize the dose of sotorasib would not be surprising to drug developers outside of oncology, as almost all drugs undergo randomized dose-ranging phase II trials before a phase III registration trial, 7,8 even for rare and/or life-threatening diseases (eg, refractory cytomegalovirus infection, septic shock, and Huntington's disease). . FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . Due to the limitations of clinical trials, potential adverse events (AEs) and long-term safety issues cannot be detected. Approval: 2021 RECENT MAJOR CHANGES FDA-approved patient labeling. But Amgen is sticking to the higher dose — which earns it an additional $180,000 a year per patient. On May 28, 2021, the FDA granted accelerated approval to sotorasib (Lumakras, Amgen) for the treatment of adults with advanced non–small cell lung cancer (NSCLC) with a Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy. 1) Jun 25, 2021 · FDA has approved the first KRAS-blocking drug, called sotorasib (Lumakras). It is usually taken once daily with or without food. Dec 27, 2023 · The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for Lumakras ® (sotorasib) seeking full approval for the Aug 1, 2021 · Abstract. Revised: 05/2021 . Patient Selection 2. What is Lumykras and what is it used for? Lumykras is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the cancer is advanced, and its cells have a particular genetic change. It did, but the biotech is sticking to the higher dose, which earns it an extra $180,000 a year per patient. If 0. May 7, 2024 · The FDA told Amgen to test whether a quarter-dose of its lung cancer drug worked as well as the amount recommended on the product label. Food and Drug Administration (FDA) has approved LUMAKRAS ™ (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. G12C. Revised: 4 Given the increasing use of sotorasib, pharmacovigilance studies may play an important role in facilitating risk-benefit assessment through large real-world databases, especially for unanticipated AEs that are not documented by the label. (1. LUMAKRAS- sotorasib tablet, coated Amgen Inc-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LUMAKRAS safely and effectively. Increase IRESSA to 500 mg daily in the absence of severe adverse drug reaction, and resume IRESSA at 250 mg seven Supplemental New Drug Application for Sotorasib Submitted: 05 September 2023 Amgen Inc. The drug targets a subset of mutations in KRAS—an oncogene considered undruggable for decades—that occur in 14% of patients with NSCLC. Oct 15, 2024 · Lumakras (Sotorasib Tablets) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. 6 This mutation makes up >50% of all KRAS mutations. com Product returns For information and instructions regarding product returns, Generic Name Sotorasib DrugBank Accession Number DB15569 Background. • In the pooled safety population of NSCLC patients who received single agent LUMAKRAS 960 mg hepatotoxicity occurred in 27% of patients, of which 16% were Grade ≥ 3. May 10, 2024 · Sotorasib, a first-in-class, selective, irreversible small molecule inhibitor of the KRAS G12C protein, received accelerated approval from the United States Food and Drug Administration (US FDA) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) . 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Sotorasib, sold under the brand names Lumakras and Lumykras, is an anti-cancer medication used to treat non-small-cell lung cancer. 1,3 It is indicated in the treatment of adult patients with KRAS G12C mutant non-small cell lung cancer. Oct 5, 2023 · CC-3 Confirmatory Study CodeBreaK 200 Demonstrates Clinical Benefit of Sotorasib CodeBreaK 100 PHASE 2 Global, single-arm trial in patients with KRAS p. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to LUMAKRAS as a single agent at 960mg orally once daily in 357patients in with NSCLC and other solid tumors label - Food and Drug Administration Office. HUMAN PRESCRIPTION DRUG LABEL: 1: 55513-504: TABLET, COATED: THOUSAND OAKS, Calif. May 20, 2024 · Outcome limitation. 4% (grade 3) of patients who Co-administration of sotorasib with a PPI (omeprazole) or an H2 receptor antagonist (famotidine) led to a decrease in sotorasib concentrations. 3 . Sep 11, 2023 · Follow all directions on your prescription label and read all medication guides or instruction sheets. 2 Lactation 8. The mechanism by which KRAS inhibitors cause renal injury is unclear and requires further study. Sep 2, 2023 · Sotorasib is metabolized in the liver via the cytochrome P450 system, largely CYP 3A4, and is susceptible to drug-drug interactions with agents that inhibit or induce the CYP enzyme reactivity. It did and with fewer side effects. [4] [5] It targets a specific mutation, G12C, in the protein K-Ras encoded by gene KRAS which is responsible for various forms of cancer. KRAZATI is indicated for the treatment of adult patients with . Thrombocytopenia occurred in 98 of 356 (28%) patients receiving SCEMBLIX, with Grade 3 or 4 thrombocytopenia reported in 24 (7%) and Oct 5, 2023 · In a 10 to 2 vote, the FDA’s Oncologic Drug Advisory Committee (ODAC) voted that the progression-free survival (PFS) of sotorasib (Lumakras) cannot be reliably interpreted vs docetaxel in the CodeBreaK 200 (NCT04303780) study for adult patients with KRAS G12C-mutated locally advanced or metastatic non–small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received Sep 1, 2024 · Sotorasib, a first-in-class, selective, irreversible small molecule inhibitor of the KRAS G12C protein, received accelerated approval from the United States Food and Drug Administration (US FDA) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) [1]. CodeBreaK 200 has its limitations:2 the control group was given docetaxel without ramucirumab. Table 1: Dose Modifications for Use With CYP3A Inhibitors or Inducers . Sotorasib remains approved under the FDA accelerated approval pathway, with mutation: a randomised, open-label, phase 3 trial. You may take sotorasib with or without food, but take it the same way each time. Thus, sotorasib, the first irreversible inhibitor of the KRAS G12C GTPase, delivered great hope when a single arm phase 2 trial demonstrated an objective response rate (ORR) of 37. Jul 21, 2022 · Federal Food, Drug, and Cosmetic Act (FDCA) for Lumakras (sotorasib). 2 Mutant KRAS discovered in 1982 but was not considered a druggable target Dec 11, 2024 · Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. It is used in adults who have received at least one other systemic therapy; Sotorasib is approved under FDA’s Accelerated Approval Program. ” Jun 4, 2021 · We conducted a multicenter, single-group, open-label, phase 2 trial to evaluate the efficacy and safety of sotorasib as monotherapy in patients with locally advanced or metastatic KRAS p. Revised: 11/2022 . G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy. Because of the potential for adverse reactions to sotorasib in breast-fed infants, advise females not to breast-feed while receiving the drug and for 7 days after the drug is discontinued Jan 2, 2024 · The FDA has issued a complete response letter to the supplemental new drug application seeking the full approval of sotorasib for patients with KRAS G12C–mutated non–small cell lung cancer. APPROVAL & LABELING FULL PRESCRIBING INFORMATION . In May 2021, sotorasib was granted accelerated approval by the US FDA for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA Oct 1, 2024 · Although sotorasib-related renal injury AE was not observed in our study, severe acute kidney injury have reported in previous study [43]. which may lead to drug-induced liver injury and hepatitis. Food and Drug Administration (FDA) has completed its review of the company's supplemental New The FDA has approved the first KRAS-targeted therapy, sotorasib, for patients with previously treated non-small cell lung cancer with KRASG12C mutations. Discard the vial, if particulate matter or discolorations are identified. WARNINGS AND PRECAUTIONS : 5. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will review data supporting the supplemental New Drug Application (sNDA) for the full approval of LUMAKRAS ® (sotorasib) for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell Drug. Sotorasib 960 mg has comparative open-label study in the subgroup of patients with severe second stage disease, as defined by cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/µL at baseline [see FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . Take sotorasib at around the same time every day. Use the medicine exactly as directed. Nov 12, 2021 · The active substance in Lumykras, sotorasib, attaches to this altered protein inside cancer cells. 2 . Randomisation was stratified by number of previous lines of therapy in advanced disease (1 vs 2 vs >2), ethnicity (Asian vs non-Asian), and history of Lumykras (sotorasib) An overview of Lumykras and why it is authorised in the EU . Thrombocytopenia, neutropenia, and anemia have occurred in patients receiving SCEMBLIX. Find patient medical information for sotorasib oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Oct 22, 2023 · In this phase 3, multicenter, open-label, Li X, et al. F. , warmth, erythema, itching) Interrupt or slow infusion of COSELA. ), a RAS GTPase family inhibitor, for adult patients with KRAS G12C ‑mutated See full list on medlibrary. Physician Labeling; PMA Database Entry LUMAKRAS is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Withhold, reduce the dose , or permanently discontinue KRAZATI Jan 13, 2024 · CodeBreaK 2001 was a randomised, open-label phase 3 trial assessing sotorasib's efficacy compared with docetaxel chemotherapy in patients with KRASG12C advanced non-small-cell lung cancer who had received at least one previous line of therapy. LUMAKRAS Dosing Confirmed at 960 mg Once-Daily for Patients With KRAS G12C-Mutated NSCLC Under Accelerated Approval. gov 6 Sotorasib in the Press “Amgen unveils its first Krasinhibitor in clinical trials: AMG 510 shuts down a mutant version of the • Open-label trials are susceptible to bias May 25, 2022 · content of labeling [21 CFR 314. On May 28, 2021, the U. 21, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U. Sotorasib exhibits non-dose proportional pharmacokinetics and clinical responses at lower doses; therefore, we evaluated the efficacy and safety of sotorasib 960 mg and 240 mg. Take sotorasib exactly as directed. Swallow the tablets whole. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of sotorasib in the pediatric population. E. Hypersensitivity • Adverse Reaction Severity Dosage Modification Hemorrhagic Events [see Warnings and or • • • • •. 1 Adjuvant Treatment of EGFR Mutation-Positive Non Sotorasib (AMG510) is a first-in-class covalent KRAS G12C inhibitor that targets the inactive form of KRAS through covalent binding to the exposure cysteine residue on the “switch pocket II” of the KRAS-GDP isoform. 3) • Adult patients with locally advanced or metastatic solid tumors with a full prescribing information: contents* warning: addiction, abuse, and misuse; life­ threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from Grade 1: Tenderness with or without symptoms (e. It also sets the stage for additional KRAS inhibitors already in development, researchers said. The bottle has a child-resistant closure. CodeBreaK 100 was a single-arm, open-label, global, multicenter clinical trial with the Phase 2 portion evaluating LUMAKRAS ® (sotorasib) in 126 patients with locally advanced or metastatic KRAS G12C–mutated NSCLC who progressed on prior therapy. 3 Sotorasib was granted accelerated approval by the US Federal Drug Administration (FDA) on May 21, 2021 for the treatment of Sotorasib did not cause adverse developmental effects and did not affect embryo-fetal survival at doses up to 540 mg/kg. FDA Assessment: An expiration dating period of 24 months may be granted when stored at the proposed storage conditions. Among patients with hepatotoxicity who required dosage modifications, 64% required treatment with corticosteroids. Content of labeling must be identical to the enclosed labeling (text for the Prescribing Information), with the addition of any labeling changes in pending “Changes Oct 5, 2023 · www. Clin Cancer Res 2022;28:1482-1486. Drug Class/Mechanism of Action Sotorasib is a small molecular inhibitor that binds irreversibly to KRAS p. None . Oct 8, 2020 · Indication Sotorasib is indicated for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS p. Orphan drugs are medicines developed to help treat, prevent or diagnose rare “orphan” diseases, which are conditions that each affect fewer than 200,000 people in Sep 13, 2024 · Background: The KRAS G12C mutation, prevalent in various malignancies, including non-small cell lung cancer (NSCLC), represents a unique therapeutic target. 8 months in patients whose disease had advanced despite treatment wi … Oct 5, 2023 · The FDA granted accelerated approval to sotorasib in 2021 based on objective response data from the single-arm CodeBreaK 100 trial, making it the first targeted agent for treating tumors with KRAS FDA-approved patient labeling. 1 ; Patient Selection Sotorasib: a KRAS G12C inhibitors Drug, Initially developed by Amgen, Inc. g. The approval, which covers the use of sotorasib for some patients with advanced lung cancer, was based on the results of the CodeBreak100 trial. Sotorasib was the first approved KRAS inhibitor granted marketing authorisation by the US Food and Drug administration (FDA) by use of the accelerated approval pathway for patients with advanced non-small-cell lung cancer (NSCLC) with the KRASG12C mutation. FDA-approved patient labeling. INDICATIONS AND USAGE . May 13, 2024 · For patients with the KRAS G12C genetic mutation, this test may help identify if treatment with the drug LUMAKRAS (sotorasib) will be appropriate. 5 . 2. Approval: 2021. Revised: 2/2021 . 1 The request to examine different dosages was supported by nonlinear pharmacokinetic drug exposure, similar target saturation, and similar tumor Call your doctor for medical advice about side effects. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full Sotorasib comes as a tablet to take by mouth. 1 % at 960 mg daily (CodeBreaK 100) [1], leading to accelerated US Food and Drug Sep 1, 2024 · Sotorasib, a first-in-class, selective, irreversible small molecule inhibitor of the KRAS G12C protein, received accelerated approval from the United States Food and Drug Administration (US FDA) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) [1]. Apr 14, 2022 · Abstract. LUMAKRAS® (sotorasib) Page 3 of 28 RECENT MAJOR LABEL CHANGES 4. You may report side effects to FDA at 1-800-FDA-1088. One Amgen Center Drive Thousand Oaks‚ CA 91320-1799 . Sotorasib is usually taken once per day. Crossref. Adagrasib and sotorasib, two FDA-approved agents specifically targeting this mutation, have shown promise in clinical trials. May 28, 2021 · Today, the U. phase I of CodeBreaK 100 was a dose exploration (part 1) and dose expansion (part 2) study aimed at evaluating the safety, tolerability, PK and pharmacodynamics of sotorasib in adult patients with KRAS G12C-mutated advanced NSCLC, colorectal Aug 6, 2021 · Sotorasib (LUMAKRAS™) is a RAS GTPase family inhibitor being developed by Amgen for the treatment of solid tumours with KRAS mutations, including non-small cell lung cancer (NSCLC) and colorectal cancer. May 10, 2024 · Sotorasib 960 mg once daily is approved to treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). gov. Coadministration of LUMAKRAS with Acid-Reducing Agents . Amgen Provides Regulatory Update on Status of Lumakras (sotorasib) May 28, 2021: Approval FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Apr 28, 2021: Amgen Provides Updated Information on Lumakras (sotorasib) Dose Comparison Study: Feb 16, 2021 Sotorasib is an inhibitor of KRASG12C, a tumor-restricted, mutant-oncogenic form of the RAS GTPase, KRAS. human prescription drug label: tablet, coated: oral: nda: 214665: lumakras: sotorasib: 2024/11/04: 2021/05/28-; 2023/02/02-; 2024/06/27-2021: amgen inc Take this medication by mouth. G12C–mutated non–small-cell lung cancer who had received at least Dec 26, 2023 · THOUSAND OAKS, Calif. , Feb. Jan 30, 2024 · In the case of sotorasib, payers can ignore the FDA label on the basis of ethical and financial arguments, and insist on reimbursing only the 240-mg dose owing to the fact that the additional 720 THOUSAND OAKS, Calif. Strong CYP3A4 Inducers . 8 months in patients whose disease had advanced despite treatment with standard therapies, namely platinum-based chemotherapy and PD-1–PD-L1 inhibitors. 1 H EPATOTOXICITY Sotorasib can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis. LUMAKRAS. 1 . On December 7, 2020, FDA granted sotorasib Breakthrough Therapy Designation which is reserved for drugs that have. yaaiq kjh lbkc zztbxa xuty vzrj paqsl gxctt rgmyxk entn