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Merck's (MRK) Keytruda Gets FDA Nod for Solid Tumor Cancers

Published on 25 May 2017 back to previous

Merck & Co., Inc. MRK announced that its anti-PD-1 therapy, Keytruda, has received accelerated approval for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. Also, the label will be expanded to include MSI-H or mismatch repair deficient colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

In a separate press release, Merck announced that the FDA has granted priority review to its supplemental biologics license application (sBLA) for label expansion of Keytruda for the treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma. The FDA is expected to give its decision on Sep 22.

Presently, Keytruda is approved in the U.S. and EU for the treatment of previously untreated metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express high levels of PD-L1 and previously treated metastatic NSCLC in patients whose tumors express PD-L1, as well as advanced melanoma. In the U.S. it is also approved for previously treated recurrent or metastatic head and neck cancer (HNSCC).

Merck's shares are up 9.8% year to date, comparing unfavorably with an increase of 10.2% witnessed by the Zacks classified Large-Cap Pharma industry.