FDA Grants Accelerated Approval to Bristol Myers Squibb's Krazati for Colorectal Cancer

Bristol Myers Squibb (BMS) has received accelerated approval from the US Food and Drug Administration (FDA) for its KRAS inhibitor, Krazati (adagrasib), to be used in combination therapy for certain colorectal cancer (CRC) patients. This approval is specifically targeted at adults with locally advanced or metastatic colorectal cancer carrying the KRASG12C mutation, a genetic abnormality found in approximately 4% of CRC patients and historically difficult to manage.

The combination treatment with Krazati has been sanctioned for patients who have already undergone chemotherapy regimens involving fluoropyrimidine, oxaliplatin, and irinotecan. CRC ranks as the third most commonly diagnosed cancer worldwide, with over 106,000 new cases expected in the United States this year alone.

Krazati, administered orally twice daily, functions as a small-molecule inhibitor targeting the KRASG12C mutation. The drug is already approved in the US for treating specific cases of non-small cell lung cancer (NSCLC). The latest FDA approval is based on promising data from the phase 1/2 KRYSTAL-1 study, where Krazati in combination with cetuximab showed a confirmed objective response rate of 34% and a median duration of response of 5.8 months.

The FDA's accelerated approval pathway means that continued approval for this indication could depend on the outcomes from additional confirmatory trials. Wendy Short Bartie, Senior Vice President of US Oncology and Hematology at BMS, heralded this new approval as a significant achievement for the company and the patients it aims to serve. She expressed pride in making Krazati available to CRC patients, marking it as the first KRASG12C inhibitor to receive FDA approval beyond its use in NSCLC. Bartie also mentioned the company's ongoing commitment to further evaluating Krazati through its development programs.

BMS came to possess Krazati through its recent $5.8 billion acquisition of Mirati Therapeutics, a deal finalized in January. This acquisition not only included Krazati but also other oncology assets such as MRTX1719, which has shown promising preliminary efficacy data in various tumor types, including NSCLC and melanoma. Giovanni Caforio, the then CEO of BMS, commented during the buyout announcement in October that the company was eager to integrate these assets into its portfolio and expedite their development to provide more treatment options for cancer patients.