Amgen's Lumakras Gets FDA Nod for Expanded Use in Colorectal Cancer

Core Viewpoint - Amgen's KRAS inhibitor, Lumakras, has received FDA approval for use in combination with Vectibix for treating KRAS G12C-mutated metastatic colorectal cancer, marking a significant advancement in targeted therapy for this patient population [1][3]. Group 1: Product Approval and Clinical Data - The FDA approved Lumakras in combination with Vectibix for adult patients with KRAS G12C-mutated metastatic colorectal cancer who have previously undergone chemotherapy [1]. - The approval was based on the phase III CodeBreaK 300 study, which demonstrated superior progression-free survival (PFS) for the Lumakras and Vectibix combination compared to standard-of-care treatments [3][4]. - The study evaluated two doses of Lumakras (960 mg daily or 240 mg daily) and showed favorable overall survival and overall response rates as key secondary endpoints [5]. Group 2: Market Performance and Sales - In the first nine months of 2024, Lumakras generated sales of $265 million, reflecting a year-over-year increase of 30.5% [7]. - Amgen's shares have decreased by 12.2% over the past year, slightly better than the industry decline of 14.1% [2]. Group 3: Future Prospects and Studies - Ongoing label expansion studies for Lumakras aim to broaden the addressable patient population, which could significantly enhance future sales [7]. - Amgen is also exploring Lumakras in phase I and II studies for non-small cell lung cancer (NSCLC), both as a monotherapy and in combination with other therapies, which may lead to additional approvals [8].