Approvals received for BRAFTOVI and MEKTOVI for Expanded Use for Two New Indications in Japan
“These approvals are based on the results of a Phase 2 study (ONO-7702/7703-03), conducted in Japan in 22 patients with unresectable BRAFV600-mutant thyroid cancer, including 5 patients with anaplastic thyroid cancer. The study met its primary endpoint of objective response rate (ORR) as assessed by the Independent Central Review in the overall patient population, which was 54.5% (12/22 cases, 95% confidence interval: 32.2 – 75.6%) in the combination therapy of BRAFTOVI and MEKTOVI. The safety profile of the combination therapy of BRAFTOVI and MEKTOVI in the study was consistent with those previously reported in the clinical trials of BRAFTOVI and MEKTOVI.”
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