The FDA has approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) for the treatment of patients with BRAF
-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.
"Now, physicians and patients have the option to consider treatment with Braftovi plus Mektovi, which has been shown to delay disease progression, improve overall survival and is generally well tolerated," added Flaherty.
The COLUMBUS findings also showed a trend toward an OS benefit with COMBO450 versus single-agent encorafenib at 300 mg daily (ENCO300). The 33.6-month median OS with COMBO450 compared favorably with the 23.5 month (95% CI, 19.6-33.6) median OS with ENCO300. The HR ratio of 0.81 (95% CI, 0.61-1.06) for the comparison was not statistically significant at the time of the data presentation (P = .123).
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