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However, the ClarIDHy trial did meet the primary endpoint of progression-free survival, based on which the firm will submit the drug for FDA approval in Q1 2021.
The study will enroll up to 125 patients who have FGFR2-altered cholangiocarcinoma and other solid tumors and are naïve to or have previously received a pan-FGFR inhibitor.
The first prospective study of BRAF-mutated cholangiocarcinoma showed a 51 percent response rate among patients treated with Novartis' Tafinlar and Mekinist.
The FDA approved the drug based on data on response rate but continued approval is contingent on the results of a randomized study showing a PFS and OS advantage.
Based on the strength of the data from the ClarIDHy trial, Agios Pharmaceuticals is aiming to submit for regulatory approval with the FDA by year end.