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How Kyprolis Overcame Serious Safety Fears To Reach Myeloma Market With Clean Label

 
• By Emily Hayes

FDA had flagged life-threatening safety issues that could have delayed approval of Onyx’s myeloma drug Kyprolis. But in the end, the agency instead opted for explicit instructions in the label to avoid risks, stopping short of a boxed warning, and a sub-study in a Phase III trial to fully assess cardiac and pulmonary risks.

Concerns about life-threatening cardiac, pulmonary and hepatic toxicities for Onyx Pharmaceuticals Inc.’s second-generation proteasome inhibitor Kyprolis (carfilzomib) were ultimately dealt with in specific instructions for adverse event management in product labeling and post-marketing requirements attached to the drug’s accelerated approval.

The next-generation proteasome inhibitor was cleared July 20 for use as up to a 10-minute intravenous infusion for multiple myeloma...

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Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

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