Bladder Cancer Canada addresses resolution of BCG shortage for bladder cancer

The Medical Advisory Board of Bladder Cancer Canada has issued a statement regarding the use of Bacillus Calmette-Guérin (BCG) for nonmuscle-invasive bladder cancer.1 Until 2021, only one brand of BCG (TICE strain) was marketed in Canada (OncoTICE).2 However, OncoTICE has been in very short supply or on allocation for several years, leading to inconsistent supplies of the drug and the need for drug rationing at many institutions across Canada.3 Read: Managing hyperkalemia caused by renin-angiotensin-aldosterone system inhibitors In 2021, Verity Pharmaceuticals introduced Verity-BCG in Canada, which contains a new strain of BCG (Russian BCG-I strain). It is indicated as adjuvant therapy after transurethral resection of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage Ta (grade 2 or 3) or T1 (grade 1, 2, or 3), without concomitant carcinoma in situ. It is only recommended for stage Ta grade 1 papillary tumours, when there is judged to be a high risk (> 50%) of tumour recurrence. Note that Health Canada issued market authorization with conditions for Verity-BCG, pending the results of trials to verify the drug’s clinical benefit.4 In view of the availability of this new BCG product, with consistent supplies in Canada, Bladder Cancer Canada (with endorsement by the Canadian Urological Association), has made the following suggestions: Every patient in need of BCG therapy should receive full-dose BCG as per the Canadian Urological Association guidelines.5 Patients with high-risk nonmuscle-invasive bladder cancer should receive full-dose BCG for six weeks of induction and three years of maintenance therapy. When patients with intermediate risk nonmuscle-invasive bladder cancer receive BCG, full-dose BCG is recommended for six weeks of induction and one year of maintenance therapy. Patients should ideally receive all BCG treatments with a single strain of BCG. However, if supply of one BCG strain is limited, patients should be switched to the other strain if necessary to ensure full-dose BCG is administered for the recommended duration of maintenance therapy.1,5 Bladder Cancer Canada notes that Verity BCG is not approved by Health Canada for the treatment of carcinoma in situ. Its use should be limited to papillary nonmuscle-invasive bladder cancer (Ta/T1) without evidence of carcinoma in situ.1 Read: New guidance on assessment and treatment of erectile dysfunction in men References 1. Bladder Cancer Canada. BCC Consensus statement on integration of TICE and Verity BCG. December 17, 2021. (accessed January 31, 2022). 2. Merck Canada. OncoTICE (Bacillus Calmette-Guérin, Strain TICE) product monograph. Kirkland, QC; April 29, 2019.(accessed January 31, 2022). 3. Drug Shortages Canada. Drug shortage report for OncoTICE. Last updated September 29, 2021.(accessed January 31, 2022). 4. Verity Pharmaceuticals Inc. Verity-BCG (Bacillus Calmette-Guérin: Strain Russian BCG-I) product monograph. Mississauga, ON; January 5, 2021. (accessed January 31, 2022). 5. Bhindi B, Kool R, Kulkarni GE, et al. Canadian Urological Association guideline on the management of non-muscle-invasive bladder cancer – full-text. Published online April 26, 2021.(accessed January 31, 2022).

Bladder Cancer Canada addresses resolution of BCG shortage for bladder cancer

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