Sesen (Vicineum) was disqualified on that In July 2021, SESEN's Vicinium was rejected by the FDA
FDA Slams Sesen Bio with CRL for Bladder Cancer Drug the U.S. Food and Drug Administration rejected its lead candidate, Viceneum (oportuzumab monatox-qqrs) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
In its Complete Response Letter, the FDA said it is unable to approve the company's Biologics License Application for Vicineum in its present form. The regulatory agency recommended additional clinical and statistical data analyses, as well as issues related to the company's Chemistry, Manufacturing and Controls (CMC).
The FDA also expressed concern about drug substance and drug product manufacturing, cell bank, characterization, resin reuse, reference standards, methods, specifications, stability, and microbiology, the company said in a conference call on Monday.
In that call, Sesen chief executive officer Tomas Cannell expressed his disappointment in the FDA's decision adding that the company will seek a Type A meeting with the regulatory agency to discuss the next steps regarding potential approval. Cannell said they anticipate the meeting will take place during the fourth quarter of this year.
The CEO also discussed that the Type A meeting would be twofold. In addition to addressing the CMC concerns, Sesen will need to confirm the primary endpoints of clinical data. He said the endpoints should be Complete Response and Duration of Response.