Bristol Myers Squibb’s Krazati failed its confirmatory study in second-line colorectal cancer, a company spokesperson confirmed to Endpoints News. The drug’s FDA approval for that indication is now at risk.
Krazati received accelerated FDA approval for second-line CRC based on tumor response data, a conditional pathway that requires a follow-up trial to confirm actual clinical benefit. The follow-up trial didn’t show it.
FDA has authority to withdraw accelerated approvals when confirmatory trials fall short. The agency has been using that authority aggressively over the past several years, working through a backlog of drugs that never completed their confirmatory work. Krazati’s colorectal cancer indication now sits in that process.
Under the regulatory procedure, BMS can request a hearing or voluntarily withdraw the indication. Either way, the drug’s shelf life in second-line CRC is in serious doubt.
BMS hasn’t announced how it plans to respond. The drug holds approvals in other tumor types, so the failure doesn’t wipe out the franchise. But it removes what was supposed to be a core growth market.
BMS acquired Krazati when it bought Mirati Therapeutics. Second-line colorectal cancer was supposed to anchor part of that deal.
Sarah Chen