Treatment for KRAS G12C-mutated metastatic CRC approved by FDA

The U.S. Food and Drug Administration (FDA) has approved sotorasib (Lumakras) plus panitumumab (Vectibix) to treat adults with KRAS G12C-mutated metastatic colorectal cancer (mCRC), according to a press release from Amgen. 

Patients approved for this treatment will have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

The approval is based on a study showing that the targeted treatment combination had superior progression-free survival (PFS) compared to the standard-of-care. This approval is the first for chemorefractory KRAS G12C-mutated mCRC.

"Lumakras plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care," said Jay Bradner, MD, executive vice president of Research and Development at Amgen. "This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer."

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.

The KRAS G12C mutation is present in approximately 3-5% of colorectal cancers, emphasizing the important role of comprehensive biomarker testing in mCRC. By detecting an actionable mutation, eligible patients are now able to receive a corresponding targeted therapy that may lead to improved responses.

"In metastatic colorectal cancer, KRAS mutations are historically associated with worse mortality rates and inferior outcomes compared to non-mutated tumors, and standard treatment options have shown minimal benefit," said Marwan G. Fakih, MD, primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope. "Designed for dual blockade of KRAS G12C and EGFR pathways, the combination of sotorasib plus panitumumab provides a needed new treatment option to better overcome cancer's escape mechanisms."

"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."

Read Amgen's media release for more information.