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FDA Clinical Hold Hits Keytruda Multiple Myeloma Studies

 
• By Alexandra Shimmings

Development of the leading immune-oncology agent has hit the buffers for multiple myeloma but failure in this relatively small market should not materially impact the product's prospects.

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Has Speeding Ahead Caused Keytruda's Wheels to Come off in Myeloma? • Source: Shutterstock

The FDA has placed a clinical hold on three combination studies of Merck & Co. Inc.'s core immuno-oncology product Keytruda (pembrolizumab) in multiple myeloma, just weeks after enrolment in two of them was suspended on the back of reports of increased deaths in patients receiving the drug.

The US agency's decision, which affects the KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023 studies, follows a review of data by the Data...

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