Developers of the drug express disappointment but plan to seek meetings with regulators in hopes of reviving the application.
Sesen Bio is a late-stage clinical company developing promising targeted fusion protein therapeutics for the treatment of cancer. But the company got bad news recently when it received a complete response letter — a form of rejection — from FDA for Vicineum (oportuzumab monatox-qqrs) for the treatment of patients with non-muscle invasive bladder cancer that hasn’t responded to a common treatment.
“We are deeply disappointed by this unexpected result, and it is an unfortunate day for patients suffering from BCG-unresponsive NMIBC.We remain dedicated to our mission to save and improve the lives of patients by bringing new treatment options to patients, and we intend to work closely with the FDA to understand next steps,” said Thomas Cannell, D.V.M., president, and chief executive officer of Sesen Bio.
BCG stands for bacillus Calmette-Guerin, a live weakened strain of the Mycobacterium bovis. Infusing BCG directly into the bladder is one treatment option for bladder cancer. It is often used after the cancer has come back. Why BCG works to combat cancer isn’t fully understood but it may coax the immune system into action in a way that mounts an immunological response to the cancer..
The FDA outlined specific recommendations for additional clinical/statistical data and analyses of Vicineum, in addition to chemistry, manufacturing, and controls issues regarding a recent preapproval inspection and product quality.
The company plans to request a Type A meeting with the FDA to discuss the future steps required before the BLA can be approved. Type A meetings with the FDA may include the following:
Vicineum targets epithelial cell adhesion molecule antigens (EpCAM) on the surface of tumor cells, and this innovative technology is expected to decrease the risk of toxicity to health tissues to improve drug safety. Additionally, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer.
The FDA accepted the Sesen Bio’s application for Vicineum in February 2021, and the application was granted priority review.
Non-muscle invasive bladder cancer is, as the name suggests, bladder cancer that occurs in the surface of the bladder cancer (the inside surface), not the muscle tissue of the organ.
Meet the Board: Otis Brawley Talks Health, Racial Disparities, Cancer Screenings and More
September 30th 2020This episode of Tuning Into The C-Suite welcomes our first of many episodes part of the new “Meet the Board” podcast series. Listeners will now hear from a member of Managed Healthcare Executive's Editorial Advisory Board once a month at the end of each month. The first guest featured is Physician and former Executive VP of the American Cancer Society, Otis Brawley. Brawley is a Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University.
Listen
3 Upcoming Urothelial Cancer Conferences
August 12th 2021At this time, two of three conferences have been reverted to a in-person and virtual format. This includes The American Urological Association (AUA) 2021 Annual Meeting and the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting.
Read More
Updated SITC Immunotherapy Guidelines for Urothelial Cancer
August 3rd 2021The Society for Immunotherapy of Cancer (SITC) released guidelines based on FDA approved immune checkpoint inhibitors (ICIs) for the treatment of urothelial cancer arising from the bladder and other areas of the urinary tract. The guidelines were based around therapies such as the programmed cell death protein 1 (PD-1) inhibitors Opdivo (nivolumab) and Keytruda (pembrolizumab) and the programmed cell death ligand 1 (PD-L1) inhibitors, Tecentriq (atezolizumab), Bavencio (avelumab) and Imfinzi (durvalumab).
Read More
Integrating Advanced Practice Providers into Oncology Settings for Managing Urothelial Cancer
July 6th 2021According to the American Urological Association, 72.5% of urologists used Advanced Practice Providers in their practice and these healthcare providers performed a variety of procedures such as a cystoscopy (procedure examining bladder lining), which assists in the diagnosis of bladder cancer. Evidence shows patients have demonstrated a growing acceptance of APPs in urology practice settings.
Read More