Merck receives five new approvals in Japan for Keytruda
Merck announced today that Keytruda, Merck's anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency, or PMDA, including three expanded uses in advanced non-small lung cancer, or NSCLC, one in melanoma, as well as a new indication in advanced microsatellite instability-high, or MSI-H, tumors. The following new approvals were all granted priority review by the PMDA: Keytruda in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of unresectable, advanced/recurrent nonsquamous NSCLC regardless of PD-L1 expression. Keytruda in combination with carboplatin and paclitaxel or nab-paclitaxel for the first-line treatment of unresectable, advanced/recurrent squamous NSCLC regardless of PD-L1 expression. Keytruda monotherapy in the first-line treatment of PD-L1-positive unresectable, advanced/recurrent NSCLC. Keytruda monotherapy as adjuvant therapy for melanoma. Keytruda monotherapy for the treatment of advanced/recurrent MSI-H solid tumors that have progressed after chemotherapy, based on results of falco Biosystems, has also been approved. In addition to the adjuvant therapy approval, dosage and administration for all patients with melanoma has been changed from intravenous infusion of 2 mg/kg over 30 minutes at a three-week interval to intravenous infusion of the fixed dose of 200 mg over 30 minutes at a three-week interval. Previously, Keytruda was approved in Japan for the treatment of curatively unresectable melanoma; PD-L1-positive unresectable, advanced or recurrent NSCLC; relapsed or refractory classical Hodgkin lymphoma and curatively unresectable urothelial carcinoma that progressed after chemotherapy.