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Game Changer: Merck's Stealth Keytruda-Chemo Filing Stirs NSCLC Market Dynamics

 
• By Lucie Ellis-Taitt

Merck & Co. has stealthily filed its highly anticipated Keytruda plus chemotherapy combination for first-line treatment of non-small cell lung cancer on the back of Phase II data, months earlier than expected and before the completion of a Phase III study.

Sparrow
Early bird Merck hopes to catch the worm, files Keytruda/Chemo combo months sooner than expected • Source: Shutterstock

The countdown to May 10 – the much earlier than expected FDA assessment date for Merck's Keytruda (pembrolizumab) plus chemotherapy treatment for first-line use in lung cancer – has begun, and the anticipated regulatory nod in this patient population has analysts editing their forecasts for the entire non-small cell lung cancer market.

On Jan. 10, the US FDA accepted Merck & Co. Inc.'s supplemental biologics license application for Keytruda in combination with chemotherapy for first-line treatment of metastatic non-squamous non-small cell...

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