On February 24, 2021 Verity Pharmaceuticals reported that it has received a notice of compliance with conditions (NOC/c) from Health Canada for the VERITY-BCG (Bacillus Calmette-Guérin [BCG]: Strain Russian BCG-I) (Press release, veritypharma, FEB 24, 2021, View Source [SID1234605586]). This approval is welcome news for patients and health care providers who have endured a Canadian and global shortage of this important bladder cancer drug.
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Bacillus Calmette-Guérin (BCG) is a proven immunotherapy of choice for bladder cancer. It is used as first-line intravesical therapy following tumor resection of non-muscle-invasive bladder cancer. Primary producers of BCG announced shortages within the last decade, leading to a worldwide scarcity of the treatment. This new source of BCG from Verity Pharma is expected to be available by mid 2021.
"Canada’s multi-year BCG drug shortage will now be a thing of the past with this approval," said Howard Glase, Chief Executive Officer, Verity Pharma. "We know these drug shortages were leading to rationing and dose sparing of this crucial bladder cancer drug and patients had delayed or even cancelled treatments. Canadian patients will now have full access to this life-saving therapy."
According to an article by the National Centre for Biotechnology Information, "physicians treating patients affected by non-muscle invasive bladder cancer (NMIBC) have been in shock during the last six years since manufacturing restrictions on the production of the first-option medicine, Mycobacterium bovis Bacillus Calmette-Guérin (BCG), have resulted in worldwide shortages."i
Bladder Cancer Canada states that bladder cancer is the 5th most common cancer in Canada and almost 12,000 people will be diagnosed with bladder cancer this year alone.
Verity has partnered with Serum Institute of India, which manufactures BCG. Serum Institute is the world’s largest manufacturer of vaccines.
"Verity is proud to continue bringing critical drugs to Canadians. VERITY-BCG is an example of our expertise in supplying life-saving therapeutic options to help fulfill unmet patient needs," said Glase.
About VERITY-BCG
VERITY-BCG is an adjuvant therapy after transurethral resection (TUR) 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 tumors, when there is judged to be a high risk (>50%) of tumor recurrence.
More information is available here: View Source