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Biotech Stocks Facing FDA Decision In January 2019

Merck
Merck

Merck & Co. Inc. (MRK) has sought FDA approval for the expanded use of its blockbuster cancer drug Keytruda as a monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer in patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.

The regulatory agency’s decision on the proposed new indication is expected on January 11, 2019.

Keytruda, co-developed and co-commercialized with AstraZeneca, is already approved for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, hepatocellular carcinoma, and Merkel cell carcinoma.

The drug fetched revenue of $3.81 billion for Merck in full year 2017, and $5.02 billion in the first nine months of 2018.

MRK closed Friday’s (Dec.21, 2018) trading at $72.90, down 0.80%.