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FDA Approves Amgen’s LUMAKRAS + Vectibix for KRAS G12C-mutated Colorectal Cancer

Approval was based on the pivotal Phase 3 CodeBreaK 300 study.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

The U.S. Food and Drug Administration (FDA) has approved Amgen’s LUMAKRAS (sotorasib) in combination with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC).

“Colorectal cancer is the third leading cause of cancer-related deaths in the United States, and fewer than one in five people diagnosed with metastatic disease survive beyond five years after diagnosis,” said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. “LUMAKRAS plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care. This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer.”

“There is an immense need for continued innovation and precision medicine to help address metastatic colorectal cancer,” said Michael Sapienza, Chief Executive Officer of the Colorectal Cancer Alliance. “This new combination approach is an important breakthrough for patients with KRAS G12C-mutated metastatic colorectal cancer, offering a new beneficial treatment option for patients living with this devastating and challenging disease.”

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