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News & Trends - Pharmaceuticals

Shortage of MSD’s BCG impacts treatment of bladder cancer patients

Health Industry Hub | May 27, 2020 |

Leading Australian urologist Professor Dickon Hayne has taken part in the BRACE trial to see whether Bacillus Calmette-Guérin (BCG) reduces the impact of COVID-19.

What he is not so happy about is the critical shortage of a slightly different strain of BCG that urologists have been using to treat people diagnosed with bladder cancer for the last 45 years.

“BCG has been in low supply since 2014,” said Hayne who is Professor of Urology, UWA Medical School, University of Western Australia, and the principal investigator of a national bladder cancer trial sponsored by the ANZUP Cancer Trials Group.

The situation has become even more critical since 2017, when one of the two overseas manufacturers of BCG stopped production, leaving MSD the sole supplier.

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“Bladder cancer patients are missing out on this optimal treatment because urologists around Australia are having real trouble accessing BCG,” said Prof Hayne.

“We really need to address this situation urgently. Bladder cancer affects about 2,800 Australians every year and not only is it becoming more prevalent, outcomes for patients are going backwards.

“In fact, among Australia’s 15 most common malignancies, bladder cancer remains the only one with survival rates that have deteriorated over the past 30 years,” he said.

With the shortage of the usual strain of BCG, the Australian Government’s Therapeutic Goods Administrator (TGA) has fast-tracked another strain but it is not widely available either.

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“Supply issues have definitely worsened since COVID-19,” Prof Hayne said. “Some non-TGA approved strains are being used after obtaining special consent from patients but this is a stop gap measure.

“What we really need is for the TGA to take urgent action to facilitate improved BCG supply for Australian bladder cancer patients.”

Prof Hayne said BCG was an essential part of treating the most common form of bladder cancer known as transitional cell carcinoma or TCC.

“Originally used to prevent tuberculosis, BCG stimulates a person’s immune system to stop or delay bladder cancer coming back after initial surgery. If the tumour becomes invasive and cancer spreads beyond the bladder walls, patient survival rates drop significantly.”


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