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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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More from Approvals

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.

New EU Filings

 
• By Neena Brizmohun

Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
• By Neena Brizmohun

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

More from Product Reviews

Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 
• By Bridget Silverman

The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.

Will US FDA’s Leadership Rediscover The Value Of Advisory Committees?

 
• By Michael McCaughan

After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.