Regulatory Decision Summary for Venclexta

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:

Drug

Medicinal ingredient(s):

venetoclax

Therapeutic area:

B-cell lymphoma 2 inhibitor

Type of submission:

Priority Supplement to a New Drug Submission

Control number:

214078
What was the purpose of this submission?

 

This Supplemental New Drug Submission (SNDS) was filed to support the market authorization of a new indication for Venclexta (venetoclax) in combination with rituximab (V+R) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. This is the indication that was authorized by Health Canada.

 

Why was the decision issued?

 

In a randomized, open-label phase 3 Study (GO28667), V+R markedly improved progression free survival (PFS), compared with bendamustine plus rituximab (BR) in patients with relapsed or refractory (R/R) CLL who had received at least one prior therapy. The PFS improvement was statistically significant and clinically meaningful with an 81% reduced risk of disease progression or death (PFS) for patients in the V+R arm. The median PFS was 18.1 months in the BR arm, and had not been reached in the V+R arm. A consistent treatment benefit in favour of the V+R arm was also observed in all subgroups evaluated for PFS. The improvement in PFS was supported by three secondary endpoints with numerally higher complete response rate and best overall response rate reported in the V+R arm. Overall survival data were immature at the time of the primary analysis but not detrimental to patients treated with V+R. The efficacy outcomes in favour of V+R arm were also reflected in other secondary endpoints including PFS in patients with 17p deletion, duration of response, time to new anti-CLL treatment.

The safety profile of V+R was generally consistent with the known safety profiles of venetoclax and rituximab as single agents and the addition of venetoclax did not increase toxicities associated with rituximab. No new safety signal was shown when compared to those from venetoclax monotherapy. Safety findings for V+R treatment are included in the Venclexta Product Monograph.

A clear and consistent clinical benefit has been demonstrated with the V+R regimen for patients with R/R CLL versus those treated with BR. The safety profile from Study GO28667 showed that V+R treatment was acceptable in patients with R/R CLL. Overall, the benefit-risk profile of the V+R regimen in patients with R/R CLL is positive and supports the proposed indication for Venclexta in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.