Braftovi and Mektovi win Japanese approval for expanded use for new indications
Japanese drugmaker Ono Pharmaceutical (TYO: 4528) has received supplemental approvals for the BRAF inhibitor Braftovi (encorafenib), and the MEK inhibitor Mektovi (binimetinib), when used in combination, in Japan for two new indications.
These indications are unresectable thyroid cancer with a BRAF mutation that has progressed following chemotherapy, and unresectable anaplastic thyroid cancer with a BRAF mutation.
Approvals are based on the results of a Phase II study, conducted in Japan in 22 patients with unresectable BRAF-mutant thyroid cancer, including five with anaplastic thyroid cancer.
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