The European Commission (EC) has granted a conditional marketing authorization for Amgen’s LUMYKRAS (sotorasib) to treat advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation in adults. NSCLC is the leading lung cancer diagnosis globally and includes adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Mutations in KRAS protein are the most prevalent mutations in NSCLC and are almost exclusively found in patients with adenocarcinoma, the most common type of lung cancer. The drug, LUMYKRAS (sotorasib), is an orally administered KRAS G12C inhibitor and has been approved for patients who have undergone at least one systemic therapy, such as chemotherapy. As a class of cancers, NSCLCs are often insensitive to chemotherapy and require a surgical resection. The U.S. Food and Drug Administration (FDA) was first to authorize an accelerated approval for LUMYKRAS (sotorasib) in May of 2021. Amgen is a California-based biopharmaceutical company that develops therapies to address unmet oncological challenges.
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