The US FDA Rejects Sesen Bio’s Vicineum (oportuzumab monatox-qqrs) for the Treatment of BCG-Unresponsive NMIBC

August 16, 2021 Auto Bot FDA, regulatory 0

Shots:

  • The company has received the FDA’s CRL declining the approval of Vicineum’s BLA to treat BCG-unresponsive NMIBC
  • The FDA has provided recommendations to conduct additional clinical/statistical data and analyses of roxadustat in addition to CMC issues related to a recent pre-approval inspection and product quality
  • The company plans to meet with the FDA as soon as possible to discuss the next steps for regulatory approval. Additionally, the therapy is currently in a P-III registration trial in the US for the treatment of BCG-unresponsive NMIBC

Click here to­ read full press release/ article | Ref: Businesswire | Image: Businesswire

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