Five new approvals for pembrolizumab in Japan

March 7, 2019 0 By FM

P embrolizumab (Keytruda) has been granted approval in Japan for the first-line treatment of advanced non-small lung cancer (NSCLC) as both monotherapy and in combination with chemotherapy.

Pembrolizumab is the first anti-PD-1 approved in Japan with new MSI-H indication, regardless of tumour type, Merck said.

Pembrolizumab has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for three expanded uses in advanced NSCLC, one in melanoma, as well as a new indication in advanced microsatellite instability-high (MSI-H) tumours.

PDMA has granted new approvals following priority review for pembrolizumab in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the first-line treatment of unresectable, advanced/recurrent nonsquamous NSCLC regardless of PD-L1 expression; Pembrolizumab 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; Pembrolizumab monotherapy in the first-line treatment of PD-L1-positive unresectable, advanced/recurrent NSCLC; Pembrolizumab monotherapy as adjuvant therapy for melanoma and pembrolizumab monotherapy for the treatment of advanced/recurrent MSI-H solid tumours that have progressed after chemotherapy.

A companion diagnostic to detect MSI-H, the MSI test kit FALCO by FALCO Biosystems Ltd., has also been approved.

In addition to the adjuvant therapy approval, dosage and administration for all patients with melanoma have been changed from an 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, pembrolizumab 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.

Pembrolizumab is marketed by MSD in Japan and is co-promoted with Taiho Pharmaceutical Co., Ltd.