Summary of Cancellation for Aliqopa
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:
Contact:
Bureau of Metabolism, Oncology, and Reproductive Sciences, Pharmaceutical Drugs Directorate
Medicinal ingredient(s):
copanlisib dihydrochloride
Therapeutic area:
Antineoplastic Agents
Type of submission:
New Drug Submission
Control number:
255077
Decision issued:
No decision was issued by Health Canada. The sponsor cancelled its submission before a final decision was issued.
Date of cancellation:
2021-12-21
What was the purpose of this submission?
This New Drug Submission (NDS) was filed in support of marketing authorization for Aliqopa (copanlisib) for two indications:
- in combination with rituximab for the treatment of adult patients with previously treated B-cell indolent non-Hodgkin lymphoma (iNHL), including follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia; and
- as monotherapy for the treatment of adult patients with follicular lymphoma or marginal zone lymphoma who have received at least two prior therapies.
The review of the NDS was under the ACCESS Consortium New Active Substance (NAS) Work Sharing Initiative (NASWSI) with Health Canada, the Australian Therapeutic Goods Administration (TGA), and Swissmedic.
What did the company submit to supports its submission?
The sponsor had submitted following studies to supports its submission:
- Study 17067 (CHRONOS-3) was evaluated as the pivotal efficacy/safety study for the copanlisib + rituximab combination therapy in iNHL indication.
- Study 16349 Part B [CHRONOS-1] was evaluated as the pivotal efficacy/safety study for the copanlisib monotherapy for Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) indication.
The sponsor had also provided supportive efficacy data for the copanlisib monotherapy indication from four Phase 1/2 monotherapy studies: study 16349 Part A (Phase 2 study; iNHL and aNHL patients); study 17792 (Phase 1 study, Japan), study 16866 (Phase 1 study, China), and study 12871 (Phase 1 study, United Sates).
The sponsor also submitted quality, non-clinical data packages, labelling information, and a post-market Risk Management Plan.
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?
Health Canada’s review of the submission was incomplete when the submission was cancelled.
At the time of the cancellation, Health Canada had identified concerns during the review related to the product’s efficacy and safety and was about to notify the sponsor of these concerns through the delivery of a clarification request. The NDS was cancelled by the Sponsor on 21 December 2021.
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.
Manufacturer:
Bayer Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2021-07-26