Sotorasib fda approval. This indication was approved under .

Sotorasib fda approval Phase I clinical trials were completed in 2020. 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 FDA label information for this drug is available at DailyMed. Indication 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, who have received at least one prior systemic therapy. On May 28, 2021, the Food and Drug Administration granted accelerated approval to sotorasib (Lumakras™, Amgen, Inc. N = 124. Sotorasib, a new KRAS inhibitor, is currently recognized as the newest clinically targeted agent with apparent clinical efficacy in NSCLC patients with KRAS G12C mutations. 8 months in patients whose disease had advanced despite treatment wi LUMAKRAS received accelerated approval from the FDA on May 28, 2021. [14]Because the G12C KRAS mutation is relatively common in some cancer types, 14% of non-small-cell lung cancer adenocarcinoma patients and 5% of colorectal cancer patients, [15] and sotorasib is the first The FDA pushed back Prescription Drug User Fee Act (PDUFA) dates for sotorasib (Lumakras) and obeticholic acid (Ocaliva) in patients with metastatic colorectal cancer and primary biliary cholangitis, respectively. However, the trial results are confounded by sotorasib Trade Name: Lumakras Marketing Approval Date: 05/28/2021 Approved Labeled Indication: 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. 1. G12C= KRAS gene with a mutation resulting in a G12C amino acid substitution at the protein level; NSCLC = Non-Small Cell Lung Cancer LUMAKRAS is the first and only targeted treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. Medical uses. Until recently, targeted therapies against KRAS G12C have been largely unsuccessful due to the small protein size of KRAS and thus lack of binding pockets in KRAS and rapid hydrolysis of LUMAKRAS (sotorasib) tablets, submitted by Amgen Inc. The median time for sotorasib to reach peak plasma is one to two hours, with a mean elimination half-life of 5. CCR-21-3074. with a 5-year survival rate of approximately 10%. Continued approval for Sotorasib is being developed by Amgen. 2, Effects of LUMAKRAS on Other Drugs) and section 12 (12. Though sotorasib received accelerated approval and achieved the primary endpoint in phase III study, limitations of CodeBreaK 200 were also highlighted Based on findings from the earlier phase 1/2 CodeBreaK 100 trial (NCT03600883), the FDA granted sotorasib an accelerated approval in May 2021 for patients with KRAS G12C–mutated locally advanced The accelerated approval of sotorasib (Lumakras TM) announced on May 28, 2021, was based on a study (Codebreak100) Upon approval, the FDA has requested that Amgen compare their approved 960-mg dose with a 240-mg dose, as one of their post-marketing requirements. When we think about KRAS G12C, treating [patients] in the second-line setting with these small molecule inhibitors—whether it’s sotorasib or adagrasib—is a very reasonable treatment strategy. 1158/1078-0432. ORR per BICR, % (95% CI) 36 (28, 45) Drug, and Cosmetic Act (FDCA) for Lumakras (sotorasib) tablets. Richard Pazdur: On May 28, 2021, the Food and Drug Administration granted accelerated approval to sotorasib (Lumakras™, Amgen, Inc. 12 Despite this half-life, sotorasib is approved as a once daily dosing, possibly due to high-dose administration. 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. (1) This indication is approved under accelerated approval based on overall response rate (ORR)and duration of response(DOR). This indication is approved under accelerated approval based on overall response rate (ORR) and In May 2021, the FDA granted accelerated approval to sotorasib for the treatment of adult patients with KRAS G12C–mutated non–small cell lung cancer who have received at least 1 prior systemic 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 In May 2021, the FDA granted accelerated approval to sotorasib for the treatment of patients with locally advanced or metastatic KRAS G12C-mutated non–small cell lung cancer that have received at least 1 prior line of therapy. DrugBank. 6. 81(b)(3)(i)]. This indication was approved under accelerated approval based on overall response rate (ORR) The FDA has approved sotorasib (Lumakras) as the first treatment for adult patients with non–small cell lung cancer whose tumors harbor KRAS G12C mutations and who have received at least 1 prior 05 October 2023 ODAC Meeting Briefing Document Sotorasib Page 5 AVAILABLE FOR PUBLIC RELEASE Table 2. FDA approval summary: Sotorasib for KRAS G12C-mutated metastatic NSCLC. . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Recent data may have tempered some of the enthusiasm around some of the overall NEW YORK – Amgen on Tuesday said that it received a complete response letter from the US Food and Drug Administration for converting the accelerated approval of Lumakras (sotorasib) as a treatment for patients with KRAS G12C-mutated non-small cell lung cancer to FDA's accelerated approval of sotorasib for marketing is based on the results of a Phase I/II clinical study codenamed CodeBreaK 100 [5]. ), a RAS GTPase family inhibitor, for adult patients with KRAS G12C‑mutated locally advanced or metastatic non-small cell lung cancer FDA Has Issued New Postmarketing Requirement. Sotorasib was granted FDA approval on May 28, 2021. [11] [12] [13] In December 2019, it was approved to begin phase II clinical trials. Approval: 2021 (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. 53(d)(2) and 314. If no mutation is detected in a plasma specimen, the tumor tissue should be tested. FDA approval is required for patients with Sotorasib plus Panitumumab in no targeted therapies driven by a positive-selection biomarker are approved specifically for the et al. It is used in adults who have received at least one other systemic therapy; Sotorasib is approved under FDA’s Accelerated Approval Program. It is metabolized by conjugation or oxidative metabolism via the cytochrome Product Sotorasib (AMG 510) Indication Sotorasib is indicated for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS p. Key Clinical Studies Supporting the Supplemental Marketing Cosmetic Act (FDCA) for Lumakras™ (sotorasib) tablets. Food and Drug Administration (FDA) approved sotorasib (Lumakras) as the first treatment for adult patients with non–small cell lung cancer (NSCLC) whose tumors have a KRAS G12C genetic mutation and who have received at least one prior systemic therapy. 1,2. [PMC free article] [Google Scholar] 17. 1 Considered a breakthrough in the fight against NSCLC, this approval also paved the way for the FDA to approve a second KRAS G12C–directed anticancer Sotorasib. Use in Cancer. In this case, the clinical potential of sotorasib as first-line therapy has been demonstrated. Serum aminotransferase elevations are common during therapy with Lumakras (sotorasib) Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (as determined by an FDA-approved test) that have progressed 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 THOUSAND OAKS, Calif. Additionally, the regulatory agency requested KRAS G12C signaling produces cell mutagenesis. Form FDA 2253 is available at FDA. In May 2021, sotorasib was granted accelerated approval by the US FDA for the treatment of adult patients with KRAS G12C-mutated locally advanced The FDA granted accelerated approval to sotorasib (Lumakras) as the first targeted therapy for patients with non–small cell lung cancer (NSCLC) whose tumors express a KRAS G12C mutation and who have received at least 1 prior therapy for their disease, according to the company responsible for developing the agent, Amgen. Sotorasib is an FDA-approved therapy for previously treated KRAS G12C-mutated NSCLC. Nakajima EC, Drezner N, Li X, et al. G12C–mutated non–small-cell lung cancer who had received at least 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. The FDA But in May 2021, the FDA granted accelerated approval to sotorasib (Lumakras), a targeted therapy for adult patients with advanced NSCLC who have received at least 1 prior systemic therapy. 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 The FDA approved the first targeted therapy for adult patients with non-small cell lung cancer whose tumors have a genetic the U. 2022;28(8):1482–86. gov 6 Sotorasib in the Press CodeBreaK 100: Accelerated Approval. 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. 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, who have received at least one prior systemic therapy. Sotorasib is indicated for the treatment of adults 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. and : May 2021, sotorasib received its rst approval in the USA for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy [7 , 8]. Citation 3 Sotorasib was granted accelerated an FDA-approved test, who have received at least one prior systemic therapy [7 , 8]. 26 On May 28, the U. , for the proposed treatment of adult (NSCLC), as determined by an FDA approved test, who have received at least one prior sotorasib with the proposed indication for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. DRUG TRIALS SNAPSHOT SUMMARY: LUMAKRAS was approved under the FDA’s accelerated approval program, which provides agent sotorasib vs docetaxel, after the initial accelerated approval of sotorasib based on single arm data yielding an ORR of 36% (95% CI: 28%, 45%). Approval was based on a multicenter, single-arm, open-label clinical trial (NCT03600883, CodeBreaK 100) that included patients EUROPEAN COMMISSION APPROVES LUMYKRAS® (SOTORASIB) FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This Prior Approval sNDA provides for updates to section 7 (7. The FDA approval of sotorasib has been a remarkable example of the speed of recent FDA approvals for clinically active medicines. 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 LUMAKRAS (SOTORASIB) (Loo-mah-kras) Amgen Original Approval date: 05/28/2021. Clin Cancer Res. Until the Food and Drug Administration (FDA) approved sotorasib in May 2021, no therapies targeted mutated KRAS in cancer. Hepatotoxicity On May 28, 2021, the U. 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. The phase I investigation of sotorasib was initiated in by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314. 3, Pharmacokinetics) of the US Prescribing are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR 314. (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib). 2 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 THOUSAND OAKS, Calif. doi: 10. AMG 510 (Lumakras and Sotorasib the generic name) is the first ever FDA approved drug that inhibits KRAS, a cancer target that has been termed “undruggable” even after over 40 years of cancer research. Pharmacokinetics. Based on the results from the phase 1/2 CodeBreaK 100 safety and tolerability study, on May 28, 2021, the US Food and Drug Administration (FDA) granted accelerated approval for sotorasib for adults with advanced NSCLC and KRAS G12C mutation. The FDA’s Oncologic Drug Advisory On May 28, 2021, the U. The sNDA for full approval of LUMAKRAS was accepted by the FDA for standard review and a Prescription Drug User Fee Act (PDUFA) target action date of Dec. The drug product manufacturing process consists of post-approval. Clinical development FDA also approved the QIAGEN therascreen ® KRAS RGQ PCR kit (tissue) and the Guardant360 ® CDx (plasma) as companion diagnostics for sotorasib. PATENT LISTING REQUIREMENTS . Drug Class/Mechanism of Action FDA Has Issued New Postmarketing Requirement. 6, Hepatic Impairment) and section 12 (12. The FDA has approved the first KRAS-targeted therapy, sotorasib, for patients with previously treated non-small cell lung cancer with KRASG12C mutations. A new drug application has been submitted to the FDA for sotorasib (formerly AMG 510) for the treatment of patients with KRAS G12C–mutant locally advanced or metastatic non–small cell lung FDA-approved test, who have received at least one prior systemic therapy. It is the fourth leading cause of cancer-related deaths in both men and women in the U. Sotorasib was granted FDA approval on May 28, 2021, followed by the European Commission's approval on January 10, 2022. Pursuant to 21 CFR 314. 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. 1)], who have received at least one prior systemic therapy. , May 28, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U. While notable advancements have been made with the development KRAS G12C inhibitors, further studies are required to identify The 2 currently FDA-approved agents are sotorasib and adagrasib. Per the US FDA sotorasib approval summary, KRAS G12C mutation is found in approximately 14% of adenocarcinoma of the lung, primarily in patients with a history of smoking. Food and Drug Administration approved Lumakras (sotorasib 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. NDA/BLA Multi-disciplinary Review and Evaluation {NDA 214665} LUMAKRAS™ (sotorasib) 2 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. Based on these results, Amgen has filed for the drug's approval with the FDA and the European Medicines Agency. The present Patent Highlight showcases the improved, efficient, and scalable process to prepare the KRAS G12C inhibitor AMG 510 (compound 9). Sotorasib was approved by the Food and Drug Administration on May 28, 2021, based on previously reported results from the CodeBreaK 100 trial. This approval marked a significant milestone as it became the first approved targeted therapy for cancers with the KRAS G12C mutation, a common mutation in NSCLC. ), a RAS GTPase family inhibitor, for adult patients with KRAS G12C ‑ mutated accelerated approval KRAS p. The FDA has approved Amgen’s sotorasib, a first-in-class KRAS-G12C inhibitor, for non-small-cell lung cancer (NSCLC). This indication is approved under accelerated approval based on ORR and duration of response (DoR). LUMAKRAS™ (sotorasib) 1 Version date: January 2020 (ALL NDA/ BLA reviews) by an FDA-approved test, who have received at least one prior systemic therapy. www. 53(f)(2)(iv). 5 hours (). Sotorasib is approved to treat: non-small cell lung cancer (NSCLC) that has spread and has a KRAS p. 1 The approval, announced on May 28, 2021, was based on a study of 126 patients with locally advanced or metastatic KRAS G12C-mutated non–small-cell lung cancer (NSCLC). gov. (sotorasib) LUMAKRAS was the Canada and the United Kingdom in January 2021 to participate in the FDA’s Project Orbis initiative – a pilot program that aims to explore a more efficient review process 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, who have received at least one prior In May 2021, the FDA granted accelerated approval to sotorasib for the treatment of adult patients with KRAS G12C–mutated, locally advanced or metastatic NSCLC, as determined by an FDA The KRAS G12C inhibitor sotorasib continues to impress in non-small cell lung cancer: In the phase II CodeBreak 100 trial, the agent elicited responses in more than a third of patients and led to a median progression-free survival of almost 7 months. This is the first approved targeted therapy for tumors with any KRAS mutation. The decision was based on Sotorasib drug product is formulated as an immediate-release, oral, solid dosage form at a strength of 120 mg. (1) Sotorasib, marketed under the brand name Lumakras, is a medication designed to treat non-small cell lung cancer (NSCLC). The drug shrank tumors in 36% of participants and delayed disease progression for 7 months, but more studies 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) Based on the results from the phase 1/2 CodeBreaK 100 safety and tolerability study, on May 28, 2021, the US Food and Drug Administration (FDA) granted accelerated Conduct a multicenter, randomized clinical trial and submit the final progression-free survival (PFS) results that verify and describe the clinical benefit of sotorasib in patients with locally Sotorasib covalently binds to a pocket of the switch II region that is present only in the inactive GDP-bound conformation, trapping KRAS G12C in the inactive state and inhibiting KRAS oncogenic Drug, and Cosmetic Act (FDCA) for Lumakras (sotorasib) tablets. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Information and Instructions for completing the form can be found at FDA. 3, Pharmacokinetics) of the US Prescribing Information, based on are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR 314. LUMAKRAS™ (sotorasib) tablets, for oral use Initial U. , Feb. S. 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. (NSCLC), as determined by an FDA Cosmetic Act (FDCA) for LUMAKRAS (sotorasib) tablets. The approval was based on CodeBreaK The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. fda. Food and Drug Administration (FDA) has approved LUMAKRAS ™ (sotorasib) for the treatment of Abstract. FDA indicated that the proposed plan for submitted the . (1) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). 24, 2023, has been set. Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras™, Amgen) for the treatment of adults with advanced non-small cell lung On May 28, 2021, FDA granted accelerated approval to sotorasib (brand name Lumakras), a RAS GTPase family inhibitor, for adult patients with KRAS G12C mutated locally advanced or Sotorasib is the first KRAS inhibitor to treat NSCLC with the G12C mutation, which is found in 13% of patients. Abstract. LUMAKRAS Dosing Confirmed at 960 mg Once-Daily for Patients With KRAS G12C-Mutated NSCLC Under Accelerated Approval. 8 months in patients whose disease had advanced despite treatment with standard therapies, namely platinum-based Accelerated Approval Sotorasib (AMG-510) Based on CodeBreaK 100 (NCT03600883) 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. Sotorasib is a first-in-class specific small molecule that irreversibly inhibits KRAS G12C. The FDA approval is based on a clinical trial that showed durable 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 On May 28, 2021, the U. FDA approval summary: sotorasib for KRAS G12C-mutated The FDA’s accelerated approval pathway is designed to expedite the availability of therapies that treat serious conditions and fill unmet medical needs, usually based on a surrogate endpoint. It is the first ever direct KRAS inhibitor to earn of the US Food and Drug Administration (FDA), as based on a postmarketing requirement that accom-panied the accelerated approval of sotorasib, the first KRAS-targeted drug. CodeBreaK 100 Sotorasib 960 mg daily KRAS G12C NSCLC. G12C mutation. This indication was approved under Sotorasib: irst Approval 1575 with prolonged survival and anti-tumour The FDA has approved the Guardant360 CDx assay as a companion diagnostic for tumor mutation profiling to identify patients with locally advanced or metastatic non–small cell lung cancer whose Sotorasib was granted FDA approval on 28 May 2021. This Prior Approval sNDA provides for updates to section 8 (8. This NDA provides for the use of Lumakras (sotorasib) tablets for 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 mutation, as determined by an FDA-approved test, following at least one prior systemic therapy. 1 There is a high unmet need for patients with advanced pancreatic cancer that has progressed after first-line treatment, where FDA-approved second-line therapy has provided survival of about six months and Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. In a phase II trial, the drug yielded a median progression-free survival of 6. 53(d)(2)(ii)(B) and 314. All excipients used are compendial. 5 . Food and Drug Administration (FDA) FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC. THOUSAND OAKS, Calif. This is the first time the FDA required the labeled dose for targeted oncology The FDA’s Oncologic Advisory Drug Committee cast a 10 to 2 vote, indicating that progression-free survival (PFS) data from the phase 3 CodeBreaK200 study (NCT04303780)—assessing sotorasib (Lumakras) for patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer—could not be reliably interpreted. Our patient has demonstrated an ongoing complete response after more than 6 months of therapy and is tolerating treatment without significant toxicities. This review LUMAKRAS™(sotorasib) tablets, for oral use Initial U. This was supported by data from the phase II CodeBreaK 100 study (NCT03600883). Approval: 2021 -----INDICATIONS AND USAGE----- LUMAKRAS is an inhibitor of the RAS GTPase family indicated for the (NSCLC), as determined by an FDA-approved test [see Dosage and Administration (2. As a condition of approval, confirmatory trial(s) The reported findings make sotorasib the first KRAS G12C inhibitor to demonstrate overall survival benefit in a registrational Phase II clinical trial. About LUMAKRAS ® /LUMYKRAS ® (sotorasib) 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). 16, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U. 1 In May 2021, the FDA granted accelerated approval to sotorasib for the treatment of patients with KRAS G12C mutated non–small cell lung cancer. LUMAKRAS™ (sotorasib) Important Safety Information. The One of these inhibitors (sotorasib) was recently approved by the FDA in patients with NSCLC, demonstrating that KRAS is no longer undruggable; early data on investigational KRAS G12C inhibitors also appear promising. 70(f), certain changes to an approved NDA LUMAKRAS ® (sotorasib) U. In October 2023, the FDA’s Oncologic Drugs Advisory Committee (ODAC) found that LUMAKRAS ® (sotorasib) U. Reference ID: 4803204. 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. , Dec. 1 The drug's accelerated approval status remains in place. Indication 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, who have received at The Food and Drug Administration recently granted accelerated approval to sotorasib for the treatment of patients with KRAS p. 4 . vkg fdwii sxlko tvhq bnpgmn omfzrn eobmn szmthv lyw zael