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 company announced on 25 March that it received two complete response letters (CRLs) for the two biologics license applications...
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