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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer

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Additional Relevant Details “The data from KEYNOTE-010 demonstrated an overall survival benefit in patients with PD-L1 expression on one percent or more of the cancer cells,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We look forward to working with the FDA over the course of the application review process and remain committed to advancing our broad clinical program for cancers where patients are in need of new options, including lung cancer.”
http://www.mercknews...
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Catalyst Date
Occurred on:
Mar 07, 2016
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Related Keywords Sbla, Pembrolizumab, Keytruda, Pd-l1, Chemotherapy, Cancer Cells, Keynote-010