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Merck: FDA approves new indication for Keytruda

(CercleFinance.com) - US pharma giant Merck announced on Tuesday FDA approval of a new indication for Keytruda for the treatment of metastatic non-squamous non-small cell lung cancer.


The US Food and Drug Administration has approved an expanded label for Merck's immuno-therapy in combination with pemetrexed and chemotherapy for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

In a Phase 3 trial evaluating 405 patients, Keytruda, in combination with pemetrexed and platinum chemotherapy, reduced the risk of death by half compared to chemotherapy alone.

Keytruda was first approved in 2017 under the FDA's accelerated approval process.



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