FDA accepts BMS’ sNDA Krazati combo for fast review

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) submitted by pharma major Bristol Myers Squibb (NYSE: BMY) for Krazati (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024 for its decision.

Bristol Myers gained rights to the drug along with its $4.8 billion acquisition of Mirati Therapeutics, in a deal that could provide another $1 billion in contingent payments. Shortly before the deal closed last month, the European Commission granted conditional approval to the drug for adults with KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy. Krazati had already been approved for certain people with lung cancer in the USA.