NorthWest Biotherapeutics Inc (NWBO)

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Merck: Keytruda+Chemo Gets Priority Review for Lung Cancer

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ZacksJanuary 11, 2017Comment
Merck & Co., Inc.’s MRK supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, Keytruda, has been accepted under priority review by the FDA.

Merck is looking to expand the label of Keytruda, in combination with chemotherapy (pemetrexed plus carboplatin), for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations. Note that this is the first sBLA filing for Keytruda as combination therapy. Also, if approved, it would be the first treatment option to combine chemotherapy with an immuno-oncology agentfor the treatment of advanced lung cancer.