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Keytruda/Chemo Combo Approval Means Merck Holds Crown, For Now

 
• By Emily Hayes

FDA's approval of Merck's Keytruda/chemo combo based on Phase II data secures the company's position in the prized first-line lung cancer indication, but Phase III readouts from other combination trials are right around the corner.

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FDA's accelerated approval of Merck & Co. Inc.'s Keytruda/chemotherapy combination for first-line non-small cell lung cancer gives the company yet another victory in the immuno-oncology space, though readouts for other combinations could alter the market dynamics dramatically within the next year.

The US FDA granted accelerated approval on May 10 for Merck's PD-1 inhibitor Keytruda (pembrolizumab) in combination with Eli...

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Pipeline Watch: Twelve Approvals And Six Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

 
• By Alaric DeArment

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• By Kevin Grogan

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.

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• By Ian Haydock

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Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

 
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Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.