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Vicineum FDA Approval Status

Last updated by Judith Stewart, BPharm on Aug 5, 2021.

FDA Approved: No
Brand name: Vicineum
Generic name: oportuzumab monatox-qqrs
Company: Sesen Bio
Treatment for: Bladder Cancer

Vicineum (oportuzumab monatox-qqrs) is a locally administered fusion protein in development for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

  • Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A.
  • Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety.
  • On August 13, 2021, Sesen Bio announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Vicineum (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The FDA determined that it could approve the BLA for Vicineum and provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues.

Development timeline for Vicineum

DateArticle
Aug 13, 2021Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs)
Feb 16, 2021Sesen Bio Announces FDA Acceptance and Priority Review of its Biologics License Application for Vicineum
Dec 21, 2020Sesen Bio Submits Completed Biologics License Application to the FDA for Vicineum and Has Requested Priority Review

Further information

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