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Pharmaceuticals / Submissions and Approvals

FDA Approves Keytruda as Part of Lung Cancer First-Line Treatment

Nov. 8, 2018

The FDA approved Merck’s Keytruda (pembrolizumab) in combination with carboplatin and either paclitaxel or nab-paclitaxel as a first-line treatment for certain lung cancers.

The FDA approved the indication based on a 559-patient study of patients with metastatic squamous non-small cell lung cancer.

The FDA recommended dosages of 200 mg intravenously every three weeks for the drug and prior to chemotherapy when given on the same day. The agency had granted the application priority review.

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