Dr. Kamat on the Process of Meeting BCG Needs in Bladder Cancer

Pipeline Report | <b>Pipeline Report: December 2020</b>

Ashish M. Kamat, MD, discusses the process of meeting the needs for TICE Bacillus Calmette–Guérin in the treatment of patients with bladder cancer.

Ashish M. Kamat, MD, associate professor, Department of Urology, Division of Surgery, and director of Urologic Oncology Fellowship at The University of Texas MD Anderson Cancer Center, discusses the process of meeting the needs for TICE Bacillus Calmette–Guérin (BCG; TheraCys) in the treatment of patients with bladder cancer.

When Merck announced it would build a new manufacturing facility to increase its production of TICE BCG, it generated a lot of excitement in the bladder cancer community, Kamat says. However, constructing the new manufacturing facility will take time, with the building process estimated to take 5 to 6 years, according to Kamat. Additionally, after the initial building is completed, it will have to undergo regulatory review and approval processes, Kamat explains.

Moreover, microbacterium BCG itself will take time to manufacture, with experts estimating that it will be 7 to 9 years before there will be sufficient BCG to address the current shortage, Kamat notes. However, once construction and manufacturing are complete, patients will not need to be turned away, supplies will not need to be rationed, and the search for alternative treatments won't be necessary, according to Kamat.

Despite this, looking for alternative treatments to BCG is recommended for the time being, as these treatments can be studied and approved between now and when the new facility completed, Kamat concludes.