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FDA Accepts Filing for Binimetinib/Encorafenib Combo in BRAF+ Melanoma

Jason M. Broderick @jasoncology
Published: Wednesday, Sep 13, 2017

Ron Squarer

Ron Squarer
The FDA has accepted new drug applications (NDAs) supporting use of the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma.

"The safety and tolerability of COMBO300 was similar to that of COMBO450 from COLUMBUS part 1, suggesting that the higher encorafenib dose does not expose patients to a significantly greater burden of toxicity when combined with binimetinib," Dummer said at ESMO. "Future reports will include OS, updated PFS, and long-term safety data."
Dummer R, Ascierto PA, Gogas H, et al. Results of COLUMBUS Part 2: A phase 3 trial of encorafenib (ENCO) plus binimetinib (BINI) versus ENCO in BRAF-mutant melanoma. Presented at: 2017 ESMO Congress; Madrid, Spain; September 9-12, 2017. Abstract 1215O.

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