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

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

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