Regulatory Decision Summary for Polivy
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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
Polivy, a lyophilized CD79b-targeted antibody-drug conjugate, is approved in Canada in a 140 mg/vial fill size. The purpose of this Supplement to a New Drug Submission (SNDS) is to add an additional drug product strength of 30 mg/vial to provide additional flexibility and to improve the adaptability of the vial size to various patient weights.
Why was the decision issued?
This new drug product strength did not require any new clinical trials or data to be provided given the following:
- The final formulation of the drug product has not changed;
- There were no significant changes to the chemical, biological and immunological requirements for batch release;
- The route of administration has not changed;
- A comparability assessment demonstrated that product manufactured after implementation of the change was comparable to the product manufactured before the change.
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 |
|---|---|---|---|
| POLIVY | 02515431 | HOFFMANN-LA ROCHE LIMITED | POLATUZUMAB VEDOTIN 30 MG / VIAL |