BCG Shortage: Key Facts for Bladder Cancer Patients & Families

June 2025 Update

In June, 2025 BCAN received this letter from Merck, updating us on their progress to end the BCG shortage. This quote comes from their letter:

“We believe that, barring any unforeseen circumstances, we are on track to complete the project [new manufacturing facility] on time and expect our plant to open by late 2026, following regulatory review and approval. Once operational, our facility is expected to triple our TICE BCG manufacturing capacity, which we anticipate will meet the needs of physicians and patients for the foreseeable future. This expansion represents a significant investment that reaffirms our long-standing commitment to delivering treatment for patients.”

Why Is There a Shortage of BCG?

Bacille Calmette-Guérin (BCG) has been a standard of care for many patients with non-muscle invasive bladder cancer for decades. Despite being the standard of care, some people with bladder cancer have been unable to access BCG for the last 10 years or more. Patients are being told by their urologists that BCG is in short supply, and that this shortage means they have to consider a different treatment option.

Merck & Co., Inc—the only maker and supplier of the BCG TICE® strain, informed BCAN and our Scientific Advisory Board that they expect the shortage to continue into next year because of increased global demand. To ensure fair distribution of BCG and minimize disruptions to patient care, Merck will distribute BCG in limited amounts when demand is higher than what the company can produce or has in stock.

When Will the BCG Shortage End?

Merck increased production of TICE BCG by more than 100 percent to enable it to be produced at the full extent of their manufacturing capacity. However, even with increased production, an increasing global demand is leading to supply constraints.

Why Is There a BCG Shortage in the US, but Not In Other Countries?

The BCG shortage in the United States has been primarily due to a reliance on a single manufacturer, Merck, which produces the TICE strain of BCG. This dependency became critical after Sanofi Pasteur ceased production of the Connaught strain in 2012, leaving Merck as the sole supplier for the U.S. and many other countries . In contrast, other countries have access to multiple BCG strains produced by various manufacturers . In the U.S., the stringent FDA approval process has limited the availability of foreign-produced BCG strains, contributing to the prolonged shortage.

What Is the Alternative to BCG for Bladder Cancer?

BCAN is deeply concerned about the current BCG shortage for treatments for bladder patients. Watch our June 2019 webinar about treatment options during the BCG shortage, where Seth Lerner, MD, from Baylor University College of Medicine, and Robert Svatek, MD, from University of Texas Health, San Antonio, discuss maximizing any BCG treatment you’re able to receive, plus alternatives to BCG.

Key quotes from the webinar:

• Carcinoma in situ is a high grade cancer that’s just in the lining of the bladder. Those patients should be prioritized for using full strength BCG because that clearly is the standard of care. If BCG is not available, these patients and other high-risk patients can be given a reduced dose of BCG, and many of us will combine a reduced dose of BCG with another immunotherapy drug, called Interferon.

• If BCG is not available, a preferable alternative to BCG is mitomycin (induction and monthly maintenance up to one year). Other options such as gemcitabine, epirubicin, docetaxel, valrubicin or sequential gemcitabine/docetaxel or gemcitabine/mitomycin may be considered with an induction and possible maintenance regimen.

• Patients with high-risk features (i.e., high-grade T1 with additional risk factors such as concomitant carcinoma in situ, lymphovascular invasion, prostatic urethral involvement or variant histology) who are not willing to take any potential oncologic risks with alternative intravesical agents, should be offered initial radical cystectomy, if they are surgical candidates.

Listen to a podcast about what patients can do when facing the BCG shortage

In September of 2020, BCAN, along with the American Urological Association, American Association of Clinical Urologists, Society of Urologic Oncology, Large Urology Group Practice Association and the Urology Care Foundation, released a joint statement regarding suggested strategies to help maximize the care of patients with non-muscle invasive bladder cancer. As always, it is important that these decisions be made after an informed discussion with the individual patient regarding their treatment options in the context of the ongoing BCG shortage. If you are a medical provider and have any questions about this guidance, please contact BCAN either by email or by calling us at 1-888-901-2226. 

If you want to consider enrolling in a clinical trial as an appropriate alternative management strategy to BCG treatment alone, you can find more information on BCAN’s Clinical Trial Dashboard.

News Coverage of the BCG Shortage

10/14/20 BCAN Statement on Planned Merck BCG Production Facility to Expand Capacity. Click here to read the statement.

In September 2020, BCAN, along with American Urological Association (AUA), American Association of Clinical Urologists (AACU), the Society of Urologic Oncology (SUO), the Large Urology Group Practice Association (LUGPA) and the Urology Care Foundation (UCF) issued a statement expressing concern about this ongoing shortage and its effects on the care of bladder cancer patients. Click here to read the statement.

11/27/19: CNBC -Mounting drug shortages delay treatments for patients with bladder cancer. On November 27, 2019, CNBC ran a story about the BCG shortage, addressing production and supply and distribution challenges. Click here to read the article.

06/19/2019 Washington Post Article on BCG Shortage. On June 18th, the Washington Post released an article about the BCG Shortage, and it includes statements from patients, doctors, Merck, and the FDA. Click here to read the article.

3/25/2019 BCAN Special Update- BCG Shortage: Understanding your Treatment Options. To view the recording of this program featuring Dr. Seth Lerner, Dr. Robert Svatak, and patient advocate Rick Bangs, please click here.

3/8/2019 BCG Shortage-Perspectives from Josh Meeks. Watch this short video with Josh Meeks and Alicia Morgans as they discuss the clinical treatment of High-Risk NMIBC in a BCG rationed era.

3/1/2019 SWOG Now Searches for BCG Replacement. National shortages of BCG in recent years leading some clinics and hospitals to run out, and some to ration supplies. SWOG Cancer Research Network research may help us fill the void. The same clinical trials group that helped establish the effectiveness of BCG may also help establish the effectiveness of a replacement. Read more here.

2/19/2019 Update from the AUA, BCAN, SUO, and others. To read the full statement, please click here.

2/12/2019 BCAN’s Response to the BCG Shortage. Click here to read the full statement.

2/12/2019 BCG Shortage for Urologists. Click here to open the newsletter in a new tab.