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.

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.

Videos

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


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

Ashish M. Kamat, MD, associate professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, discusses enhancing clinical trial recruitment through a novel definition of bacillus Calmette-Guérin (BCG) therapy failure in patients with nonmuscle invasive bladder cancer (NMIBC).

The investigation of new treatments for NMIBC is hampered by low clinical trial enrollment. Furthermore, designing a clinical trial after BCG treatment failure is complicated by a lack of an adequate or ethical control arm.

In a prospective study, the Urovysion FISH assay was performed during the course of BCG treatment to detect molecular progression prior to treatment failure by cystoscopy. In some cases, molecular BCG failure was detected after 6 weeks of treatment.

This early detection system provides an opportunity to conduct clinical trials with maintenance BCG as the control before full treatment failure by cystoscopy, Kamat explains. More importantly, he adds, this approach would negate any ethical concerns associated with an adequate control arm in post-BCG failure studies.

Ashish M. Kamat, MD, from MD Anderson Cancer Center, discusses enhancing clinical trial recruitment through a novel definition of BCG therapy failure in patients with nonmuscle invasive bladder cancer.

Ashish M. Kamat, MD

Articles

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

Dr. Kamat on a Molecular Definition of BCG Failure