The FDA granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.
The FDA has accepted and granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin (BCG)—unresponsive non–muscle invasive bladder cancer (NMIBC), according to an announcement from Sesen Bio, the developer of the drug.1 The regulatory agency will review the application for Vicineum within 6 months, compared with the standard 10 months from the date of the filing. The FDA is not planning to hold an advisory committee meeting to discuss the application; the agency is slated to make its final decision on Vicineum on, or before, August 18, 2021.
“We have been meeting with the FDA regularly for the past 2 years on the application for Vicineum. We understand the FDA’s position and guidance very clearly and have found the review process to be collaborative and engaging,” Thomas Cannell, DVM, president and chief executive officer of Sesen Bio, stated in a press release. “With these critical FDA decisions, we have reached an inflection point for the Company. In addition to a clear regulatory path forward, we have continued to strengthen our balance sheet in preparation for the potential launch of a product we believe represents a significant advancement over available therapies.”
A recombinant fusion protein, Vicineum, was designed to target epithelial cell adhesion molecule—specific antigens on the surface of tumor cells to deliver Pseudomonas Exotoxin A, a potent inhibitor of protein synthesis. The agent is under examination in the open-label, multicenter, single-arm, phase 3 VISTA trial (NCT024492339) as a treatment for patients with NMIBC who had previously received the current standard of care, BCG.2