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Merck’s Keytruda received one more indication and dosage form approval in Japan

Merck has announced that it has received the approval of its anti-PD-1 therapy, Keytruda (pembrolizumab) for radically unresectable, advanced, or recurrent esophageal squamous cell carcinoma (ESCC). Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for patients with ESCC who have progressed after chemotherapy.

Keytruda also received the approval of additional dosage, 400 mg every six weeks (Q6W), in addition to 200 mg every three weeks (Q3W). The dosage form received approval across all indications.

The approval is based on the global Phase 3 KEYNOTE-181 trial, which demonstrated the improvement in overall survival in Keytruda monotherapy arm compared to patients who were on chemotherapy. The median overall survival was 10.3 months in patients on Keytruda arm, 6.7 months of overall survival was observed in patients who were on chemotherapy.

Approval of the Q6W dosing regime was based on pharmacokinetic modeling and exposure-response analyses.

“We remain committed to improving outcomes for as many patients with cancer as possible, including those with esophageal squamous cell carcinoma, which is a leading cause of cancer-related death in Japan,” said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck.

Keytruda has received approval for seven types of tumors in Japan. The drug received approval for ESCC from the US FDA in August 2019.

About Esophageal Cancer

Esophageal cancer is the seventh prevalent cancer in the world. Cancer starts in the mucosa of the esophagus and extends outwards. The global incidence of esophageal cancer in 2018 was 572,000 resulting in the death of 509,000.


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