Merck & Co. Inc. (NYSE: MRK) has announced that its blockbuster drug Keytruda received a series of approvals in Japan.
The firm said that its anti-PD-1 therapy has simultaneously received five new approvals from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), including three expanded uses in advanced non-small lung cancer (NSCLC), one in melanoma, and a new indication in advanced microsatellite instability-high (MSI-H) tumors.
Dr. Roy Baynes, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, commented:
These five simultaneous approvals of Keytruda in Japan represent a significant achievement that involved extensive collaboration with the Japan Pharmaceuticals and Medical Devices Agency. We appreciate the Agency’s efforts to expedite availability of this important medicine to more patients living with cancer in Japan.
The following new approvals were all granted priority review by the PMDA:
- Keytruda 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 (based on results of the Phase 3 trial Keynote-189);
- 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 (based on results of the Phase 3 trial Keynote-407);
- Keytruda monotherapy in the first-line treatment of PD-L1-positive (Tumor Proportion Score [TPS] ≥1%) unresectable, advanced/recurrent NSCLC (based on results of the Phase 3 trial Keynote-042);
- Keytruda monotherapy as adjuvant therapy for melanoma (based on results of the Phase 3 trial EORTC1325/Keynote-054, a study sponsored by Merck and conducted in collaboration with the European Organisation for Research and Treatment of Cancer [EORTC]); and
- Keytruda monotherapy for the treatment of advanced/recurrent MSI-H solid tumors that have progressed after chemotherapy (only if refractory or intolerant to standard therapies), based on results of two Phase 2 trials, Keynote-164 and Keynote-158. A companion diagnostic to detect MSI-H, the MSI test kit FALCO by FALCO Biosystems Ltd., has also been approved.
Shares of Merck closed Wednesday at $75.59 and were down fractionally in Thursday’s premarket. The 52-week trading range is $52.83 to $80.19, and the consensus analyst price target is $81.01.