DTMT Network

US-based global pharma giant Merck has recently announced that the European Commission has approved the company’s anti-PD-1 therapy, Pembrolizumab marketed under the name of Keytruda as monotherapy for the treatment of five different types of cancers.

In a statement, Merck said that the treatment has been approved for microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumours in adults with unresectable or metastatic colorectal cancer, recurrent endometrial carcinoma, unresectable or metastatic gastric, small intestine or biliary cancer.

The EC approval has been given to Keytruda as second-line therapy in all the indications.

“Our company has a strong track record of applying for precision medicine, through biomarkers like MSI-H and dMMR, to help identify patients most likely to respond to Keytruda based on the genetic makeup of their individual cancer,” Dr Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories said.

“For patients with MSI-H/dMMR colorectal cancer, Keytruda monotherapy was approved in Europe as a first-line option in January 2021. Building on that approval, we are pleased that Keytruda is now approved for the treatment of additional MSI-H/dMMR tumours, in certain second or later-line patients with colorectal, endometrial, gastric, small intestine or biliary cancer,” he added.

“In the two studies supporting this approval, Keytruda monotherapy showed strong objective response rates and durability of response in patients with five different types of MSI-H/dMMR cancers,” said Dr Aurélien Marabelle, the Immuno-Oncologist at Gustave Roussy Cancer Centre and Professor of Clinical Immunology at the University of Paris Saclay said.

“The EU approval of Keytruda is an important milestone for patients living with these MSI-H/dMMR cancers who have had few treatment options and face worse outcomes when diagnosed at an advanced stage.”

This approval allows the marketing of KEYTRUDA monotherapy in all 27 European Union (EU) member states plus Iceland, Lichtenstein, Norway and Northern Ireland, the company informed.