Pharma companies urged to boost production of bladder cancer drug as shortage worsens

Amid a global drug shortage, thousands of patients with bladder cancer are unable to receive their recommended treatment each year. While Merck has pledged to make as many doses as it can, the company’s efforts aren't enough.

Now, the End Drug Shortages Alliance (EDSA), plus others, are calling on the pharma industry to step up to help end the shortage of Bacillus Calmette-Guerin, or BCG. 

BCG has been used to treat bladder cancer since the 1970s, the EDSA notes in a new white paper (PDF). While Sanofi and Merck supplied the treatment to global markets throughout the 1990s and 2000s, Sanofi halted production in 2017 after running into manufacturing troubles several years earlier. 

That’s left Merck shouldering the responsibility. In 2020, the New Jersey-based drugmaker pledged to build a new plant to produce the drug, but it’s not expected to come online for several more years, the EDSA reports. 

Seeking to bring awareness to the situation, the EDSA and two members, Vizient and patient advocacy group Angels for Change, recently conducted a survey of health system and hospital members to see how the shortage affects patients. 

The team found that 100% of health system or hospital respondents have implemented at least one mitigation strategy—such as switching patients to another treatment or rationing—to deal with limited supplies. Specifically, 62.5% of respondents said they had switched patients to other treatments, while 37.% said they’d implemented dose reductions between January 2019 and September 2022. Around 31% of respondents said they’d used BCG for initiation therapy only. 

BCG is the standard-of-care for intermediate- and high-risk non-muscle invasive bladder cancer. It's recommended to be used as an induction therapy for about six weeks, followed by use as a monthly maintenance therapy for about a year, according to the EDSA.

In all, the shortage means 8,300 patients are unable to get their full, recommended treatment doses per year, the EDSA says. 

Bladder cancer cases are growing in number each year, and relief from the shortage is “not within sight,” the paper adds. The team implored drugmakers to “investigate their ability to bring additional supply of this life-saving drug to the market.” 

For its part, Merck is operating at “maximum production capacity,” the company said in an update last month. The company's new plant, when fully operational, should triple Merck’s current capacity. But that won’t come for several years. 

Before unveiling its plans for a new plant, Merck in 2019 limited orders of the therapy. Over the last decade, the company has doubled its BCG output.