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AMGEN® FDA Approves LUMAKRASTM ( Sotorasib ) , The First And Only Targeted Treatment For Patients With KRAS G12C - Mutated Locally Advanced Or Metastatic Non - Small Cell Lung Cancer May 28 , 2021 KRAS G12C , a Driver Mutation Found in About 13 % of Patients With Non - Squamous Non - Small Cell Lung Cancer , is Now Actionable ( 1 ) Once - Daily Dosing of LUMAKRAS Demonstrated Durable Responses and a Positive Benefit - Risk Profile Biomarker Testing Critical to Identify KRAS G12C Mutation THOUSAND OAKS , Calif . , May 28 , 2021 / PRNewswire / -- Amgen ( NASDAQ : AMGN ) today announced that the U.S. Food and Drug Administration ( FDA ) has approved LUMAKRAS TM ( 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 . LUMAKRAS has received accelerated approval based on overall response rate ( ORR ) and duration of response ( DOR ) . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial ( s ) . To view the multimedia assets associated with this release , please click : https://www.multivu.com/players/English/8812853-amgen-fda-approval- lumakras - sotorasib - targeted - kras - g12c - lung - cancer / " The FDA approval of LUMAKRAS is a breakthrough moment for patients with KRAS G12C - mutated non - small cell lung cancer because there is now a targeted therapy for this common , but previously elusive , mutation , " said David M. Reese , M.D. , executive vice president of Research and Development at Amgen . " KRAS has challenged cancer researchers for more than 40 years with many deeming it as ' undruggable . ' The LUMAKRAS development program was a race against cancer for Amgen's scientists and clinical trial investigators who together have now successfully delivered this new medicine to patients in less than three years — from first patient dosed tdJ.S. regulatory approval . " The FDA approval of LUMAKRAS is based on results from a subset of patients in CodeBreak 100 , the largest clinical trial conducted to date exclusively for patients with the KRAS G12C mutation . The trial demonstrated favorable efficacy and tolerability in 124 patients with KRAS G12C mutation - positive NSCLC who had disease progression after receiving an immunotherapy and / or chemotherapy . In the trial , 960 mg of LUMAKRAS administered orally once - daily demonstrated an ORR ( a proportion of patients with ≥ 30 % decrease in tumor ) of 36 % ( 95 % CI : 28-45 ) with 81 % ( 95 % Cl : 73-87 ) of patients achieving disease control ( percentage of patients who have achieved complete response , partial response and stable disease for more than three months ) . The median DoR was 10 months . The most common adverse reactions ( ≥ 20 % ) were diarrhea , musculoskeletal pain , nausea , fatigue , hepatotoxicity and cough . Adverse reactions resulting in permanent discontinuation of LUMAKRAS occurred in 9 % of patients . " Sotorasib represents a major advancement in oncology and changes the treatment paradigm for patients with KRAS G12C - mutated non - small cell lung cancer , " said Bob T. Li , M.D. , Ph.D. , MPH , principal investigator at Memorial Sloan Kettering Cancer Center . " Patients with non - small cell lung cancer who have progressed beyond first - line treatment face a poor prognosis and have limited treatment options available to them . Sotorasib delivers a new option for these patients , and it is the first KRAS - targeted therapy to be approved after nearly four decades of research . " NSCLC accounts for approximately 84 % of the 2.2 million new lung cancer diagnoses each year worldwide , including approximately 236,000 new cases in the U.S.2,3 KRAS G12C is one of the most prevalent driver mutations in NSCLC , with about 13 % of patients with non - squamous NSCLC in the U.S. having the KRAS G12C mutation.1 Amgen's Commitment to Comprehensive Biomarker Testing and Patient Support About half of all patients with NSCLC harbor a targetable driver mutation , yet despite the integral role that biomarkers play in identifying patients who may benefit from targeted therapies , many patients are not tested . 4,5 Amgen has partnered with two companies - Guardant Health and QIAGEN ― to develop blood- and tissue - based companion diagnostics ( CDx ) : respectively , for LUMAKRAS . With the addition of these tests , patients and clinicians will have more options and flexibility for conducting KRAS G12C biomarker testing . " Biomarker testing for patients with non - small cell lung cancer is critical because it informs a patient's treatment path with a personalized and tailored approach . The only way to identify the KRAS G12C mutation is to test for it , so I urge patients to ask their care teams about comprehensive biomarker testing . It is important that patients and their healthcare providers know that KRAS G12C is now an actionable mutation , " said Andrea Ferris , president and CEO of LUNGevity . " Today's FDA approval of a therapy targeted for KRAS G12C , one of the most prevalent biomarkers in non - small cell lung cancer , brings hope to the many patients who carry this mutation and is a significant moment for the lung cancer community who need more innovative treatment options . " Amgen is committed to supporting patients with NSCLC and to helping appropriate patients with affordable access to LUMAKRAS . Patients , caregivers and physicians who need support , tools or resources can contact Amgen Assist360 ™ M ( 1-888-4ASSIST ) Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways , including free medicines through the Amgen Safety Net Foundation for qualifying individuals with no or limited drug coverage . Amgen to Webcast Investor Call on LUMAKRAS FDA Approval Amgen will host a webcast call for the investment community on Tuesday , June 1 , 2021 at 5 a.m. PT / 8 a.m. ET . David M. Reese , M.D. , executive vice president of Research and Development and Murdo Gordon , executive vice president of Global Commercial Operations at Amgen will participate to discuss the recent FDA approval of LUMAKRAS . Live audio of the investor call will be simultaneously broadcast over the Internet and will be available to members of the news media , investors and the general public .