Summary of Cancellation for Adcetris
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.
Type of submission:
Supplement to a New Drug Submission
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
What was the purpose of this submission?
The purpose of this submission was to extend the indication of Adcetris to include previously untreated patients with Stage III Hodgkin lymphoma (HL), in combination with doxorubicin, vinblastine, and dacarbazine. The sponsor proposed to replace “Stage IV HL” in the currently authorized indication with “advanced stage HL” to include patients with either Stage III or Stage IV disease.
What did the company submit to support its submission?
A phase 3, randomized, open-label, 2-arm, global, multicentre study was conducted to compare Adcetris + doxorubicin (Adriamycin), Vinblastine, and Dacarbazine (A+AVD) with the standard of care chemotherapy combination of doxorubicin (Adriamycin) + Bleomycin + Vinblastine + Dacarbazine (ABVD) in an enrolled population of 1,334 patients with Stage III or Stage IV HL (Echelon-1 trial). Patients were randomized 1:1 to receive either A+AVD (N = 664) or ABVD (N =670). At the time of randomization, 36% and 64% of patients had Stage III and Stage IV disease, respectively. The primary endpoint was modified progression-free survival (mPFS) per independent review facility and the key secondary endpoint was overall survival (OS).
The current indication of Adcetris for the treatment of previously untreated Stage IV patients was based on the primary analysis of mPFS that showed benefit of A+AVD over ABVD in the treatment of patients with Stage IV HL.
In the current submission, the sponsor provided updated data on efficacy and safety from the Echelon-1 trial during the post-treatment follow-up (PTFU). During the PTFU, patients were followed for survival and disease status every 3 months for 36 months and then every 6 months (± 14 days) until the first of progressive disease, death, or study closure. The median duration of follow-up for OS analysis was approximately 73 months.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
At the time of the cancellation, the review of the submission was ongoing. Health Canada had identified deficiencies that would not support the revised indication to include patients with Stage III disease. The sponsor chose to cancel the submission without prejudice to a refiling.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials based on this cancellation request.
Drug Identification Numbers issued: