Ono files Braftovi plus Mektovi for expanded approval in Japan
Ono Pharmaceutical (TYO: 452) has submitted to broaden the Japanese label for Braftovi (encorafenib) plus Mektovi (binimetinib), in combination with the chemotherapy cetuximab.
The expanded label would include treatment of unresectable advanced or recurrent BRAF-mutant colorectal cancer.
The submission is supported by data from the Phase III BEACON CRC study, which showed a boost to median overall survival (OS), 9 months compared with 5.4 months.
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