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Y-mAbs’ I-Omburtamab Offers Another Example Of The Limits To US FDA’s Regulatory Flexibility

 
• By Derrick Gingery

Even in a rare disease with no approved treatments, the agency shows once again that without clear efficacy data, FDA has few options for approval.

flexibility
FDA flexibility may not be extensive enough to approve I-omburtamab. • Source: Shutterstock

Regulatory flexibility afforded to rare disease products may be able to help push them closer to US Food and Drug Administration approval than those for common diseases, but Y-mAbs Therapeutics Inc. seems to have discovered the policy has a breaking point.

Y-mAbs’ I-omburtamab only reached the application assessment and advisory committee stages seemingly because the product is intended for a rare disease with no FDA-approved treatments: central nervous system/leptomeningeal (CNS/LM) metastases...

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