Regulatory Decision Summary for Verity-BCG
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this New Drug Submission (NDS), control # 221579, is to seek market authorisation for Verity-BCG for the management of non-muscle invasive bladder cancer (NMIBC). Verity-BCG is an antineoplastic agent for intravesical immunotherapy of superficial bladder cancer. Verity-BCG is composed of a live, attenuated strain of the bacterium, Mycobacterium Bovis, called Bacillus Calmette-Guérin (BCG): Russian or Moscow strain.
After evaluation of the submitted data package, Health Canada authorized with conditions, Verity-BCG for the following for the following indication:
"For treatment as adjuvant therapy after transurethral resection (TUR) of a primary superficial papillary urothelial cell carcinoma of the bladder stage Ta (grade 2 or 3) or T1, without concomitant carcinoma in situ."
Why was the decision issued?
- Clinical evidence for efficacy of Verity-BCG was based on two single-centre phase IV post-marketing surveillance studies completed in India between 2006 and 2012. Study 01 enrolled 104 patients with stage T1 urothelial cell carcinoma of the bladder for treatment with bladder instillations of Verity-BCG. Treatment consisted of an induction period followed by maintenance treatments for a period of 36 months. Study 02 enrolled 50 patients with stage T1 disease for induction followed by maintenance for a period of 12 months. These studies did not have active comparators.
- In Study 01 in the 80 mg/instillation group, 8 of 51 patients had muscle-invasive recurrence and one patient was lost to follow up during the maintenance period. At the end of 36 months of treatment with Verity-BCG, 42 (82%) patients did not have any recurrence. In the 120 mg/instillation group, 5 of 52 patients were lost to follow up. Out of the 48 remaining patients, 3 patients had muscle-invasive recurrence and 4 had non-muscle invasive recurrence during maintenance therapy. At the end of 36 months, 41 (77%) patients did not have any recurrence. The primary objective for Study 02 was to assess recurrence at 12 months for patients treated with 80 mg/instillation. At study conclusion, 79% did not recur or progress. Results for both studies were in the range of expected outcomes reported in the literature.
- Very common adverse reactions, reported in more than 10% of patients, were dysuria, hematuria and fever. Common adverse reactions, reported in 1 to 10% of patients, were urinary frequency and urgency, bladder cramps, pain, urinary tract infections and influenza-like symptoms.
- These post-marketing studies provided clinical evidence for efficacy such that the benefit-risk balance of Verity-BCG can be considered favourable. A study to confirm the efficacy of Verity-BCG entitled "multicenter, randomized, double-blind, controlled phase 3 non-inferiority study: Efficacy and safety of Verity-BCG in management of intermediate and high-risk non-muscle invasive bladder cancer in BCG-naïve patients" is necessary to confirm the benefit-risk balance for Verity-BCG and is a condition of authorisation.
- The recommended dose of Verity-BCG is two 40 mg vials per instillation (each 40 mg vial contains 1-8 x 108 Colony Forming Units). View the Product Monograph for details of the induction and maintenance regimens.
- The clinical evidence for efficacy from these post-marketing studies and the protocol for the proposed confirmatory clinical trial to be conducted in Canada were evaluated in relation to the totality of the evidence. Enhanced post-marketing surveillance would be planned for all patients treated with Verity-BCG within the context of integrated urological cancer care.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| VERITY-BCG | 02508613 | VERITY PHARMACEUTICALS INC. | BACILLUS CALMETTE-GUÉRIN (BCG) - STRAIN RUSSIAN BCG-I 40 MG / VIAL |