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FDA approves Mirati’s Krazati sNDA for colorectal cancer

The FDA has approved Mirati Therapeutics’ Krazati in combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer, or CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, according to an amended label posted to the agency’s website. On January 23, Bristol Myers Squibb (BMY) announced that it had successfully completed its acquisition of Mirati Therapeutics.

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