Pfizer (PFE) Friday said the US Food and Drug Administration approved a combination of its Braftovi cancer drug with Eli Lilly's (LLY) Erbitux medication and three other chemotherapies to treat patients with metastatic colorectal cancer with a BRAF V600E mutation as detected through an FDA-approved test.
The regulatory approval followed phase 3 study. Initial data showed patients in the active arm of the trial had an objective response rate of 61%, compared with a 40% rate in chemotherapy, with or without bevacizumab, Pfizer said.
Median duration of response for the Braftovi patients was 13.9 months, compared with 11.1 months in the other arm, the company said, adding testing is ongoing, with complete trial data to be presented at future medical meetings.
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