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Regeneron Oncology Setback Delivered By US FDA Crackdown On Accelerated Approval

Odronextamab Was Filed For FL And DLBCL

 
• By Jessica Merrill

The company received two complete response letters from the US FDA for the CD20xCD3 bispecific antibody odronextamab due to clinical trial requirements for accelerated approval.

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FDA rejected Regeneron's BLAs for odronextamab • Source: Shutterstock

Regeneron Pharmaceuticals, Inc. has been expecting to have its second cancer drug on the market shortly, a key catalyst of an ambitious oncology strategy the company embarked on several years ago. But US Food and Drug Administration approval of the CD20xCD3 bispecific antibody odronextamab for relapsed/refractory follicular lymphoma (FL) and relapsed/refractory diffuse large B cell lymphoma (DLBCL) has been delayed due to the clinical trial requirements for accelerated approval.

Key Takeaways
  • Regeneron received two complete response letters for the two BLAs for odronextamab, which both had 31 March FDA action dates.
  • The CRLs were due to the timeline of the ongoing confirmatory trials for odronextamab, not because of any issues with clinical efficacy, safety or manufacturing, Regeneron said

The company announced on 25 March that it received two complete response letters (CRLs) for the two biologics license applications for odronextamab, which both had 31 March FDA action dates

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