As urologists maneuver through the third shortage of bacillus Calmette-Guérin (BCG) during the past decade, there is a sense of urgency to find short- and long-term alternative treatments to the only FDA-approved BCG strain as a therapeutic agent for nonmuscle-invasive bladder cancer.
The incidence of bladder cancer is increasing worldwide. In the United States alone, there were 80,000 newly diagnosed cases in 2018, compared with 60,000 newly diagnosed cases 10 to 15 years ago.
Of these, nearly 45% of patients present with high-grade, noninvasive tumors. For these patients, intravesical immunotherapy with BCG remains the best bladder-sparing treatment, says Ashish M. Kamat, MD, MBBS, professor of urologic oncology (surgery) at MD Anderson Cancer Center, Houston.
The increase in new cases, as well as the recognition by both patients and their doctors that maintenance therapy with BCG is required, has led to an increase in demand—both in the United States and around the world—and the shortage.
Merck is the only manufacturer for the TICE strain of BCG for many countries, including the United States. Earlier this year, the company started to proportionally allocate the medicine across countries where it is the sole or primary supplier, including the United States, based on historical averages.
The company is producing between 600,000 and 870,000 vials annually, which is considered full capacity, but it cannot keep up with the increased demand.
Tyrone Brewer, vice president of global oncology marketing for Merck, told Urology Times the shortage has left the company as equally frustrated as urologists.
“People need to know we’re doing all we can possibly do,” he said. “We’re working with regulatory agencies to understand what options we can pursue.”
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