Merck Files Keytruda/Chemo Combo Early With FDA In 1L Squamous Lung Cancer

Also, Bristol has filed its Opdivo/Yervoy IO combination in Europe for first-line NSCLC, including squamous and non-squamous disease, based on CheckMate 227 data; some analysts expect FDA will accept the same dataset.

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Merck & Co. Inc.'s early filing of the Keytruda/chemotherapy combination in first-line squamous lung cancer with the US FDA, based just on secondary endpoint response rate data, shows once again that the company is a step ahead of the PD-1 pack, though a close competitor – Bristol-Myers Squibb Co.'s Opdivo/Yervoy combo – also could be in the running.

Merck announced May 3 that it recently submitted an sBLA for its PD-1 inhibitor Keytruda (pembrolizumab) for use in combination with carboplatin-paclitaxel or

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