Pfizer (PFE) received full approval from the US Food and Drug Administration for its drug Braftovi in combination with Erbitux and fluorouracil-based chemotherapy for the treatment of adults with BRAF V600E-mutated metastatic colorectal cancer.
The conversion from accelerated approval was based on "significant benefit in outcomes" for both progression-free survival and overall survival in a Phase 3 study, Pfizer said Tuesday in a statement.
The Braftovi combination is under regulatory review in Europe and has been approved in several other countries, Pfizer said.
Eli Lilly (LLY) manufactures and commercializes Erbitux in North America.
Pfizer shares rose 0.3% in Tuesday trading, and Lilly fell 1.4%.
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