Bristol Myers Squibb’s (BMS) KRAS inhibitor Krazati (adagrasib) has been granted accelerated approval by the US Food and Drug Administration (FDA) as part of a combination treatment for a subset of colorectal cancer (CRC) patients.
The drug has been authorised for use alongside cetuximab as a targeted treatment option for adults with locally advanced or metastatic cases of the disease who are carrying the KRASG12C mutation, which occurs in approximately up to 4% of CRC patients and has historically been challenging to treat.
Eligible patients will also have received prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
CRC is the third most commonly diagnosed cancer globally, with more than 106,000 new cases of the disease expected to be diagnosed in the US this year.
Taken orally twice daily, Krazati is a small-molecule inhibitor of KRASG12C and is already approved in the US to treat specific cases of non-small cell cancer (NSCLC).
The FDA’s latest decision was supported by positive results from cohorts of the phase 1/2 KRYSTAL-1 study, in which Krazati plus cetuximab demonstrated a confirmed objective response rate of 34% and a median duration of response of 5.8 months.
As per the regulator’s accelerated approval pathway, continued authorisation for the drug in this indication may be contingent on results from a confirmatory trial.
Wendy Short Bartie, senior vice president, US oncology and haematology at BMS, described the new approval as “an important milestone” for the company and the patients it serves.
“We are proud to make Krazati – the first KRASG12C inhibitor to be FDA approved beyond NSCLC – available to CRC patients, and look forward to further evaluating Krazati through our ongoing development programme,” she said.
BMS gained access to Krazati through its recent $5.8bn acquisition of Mirati Therapeutics.
The deal, which closed in January, also included multiple other targeted oncology assets, such as MRTX1719, which BMS said had shown “encouraging” early efficacy data across several tumour types, including NSCLC and melanoma.
Giovanni Caforio, the then chief executive officer at BMS, said at the time of the buyout announcement in October: “We are excited to add these assets to our portfolio and to accelerate their development as we seek to deliver more treatments for cancer patients.”