Summary of Cancellation for Mar-Treosulfan
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):
Treosulfan
Therapeutic area:
Antineoplastic agents
Type of submission:
New Drug Submission
Control number:
231223
Decision issued:
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
2021-06-29
What was the purpose of this submission?
This New Drug Submission (NDS) was submitted to seek market authorization for Mar-treosulfan for the palliative treatment of advanced epithelial ovarian cancer after at least one line of standard therapy.
What did the company submit to supports its submission?
This Submission Relying on Third-party Data (SRTD) contained literature and post-market experience to support the clinical effectiveness and safety of Mar-treosulfan for the proposed indication and conditions of use. This SRTD did not contain any clinical study reports. The reference product for Mar-treosulfan was Ovastat (treosulfan from medac GmbH) for the purpose of demonstrating comparative pharmaceutical and/or bioavailability characteristics.
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?
A Notice of deficiency (NOD) was issued on July 15, 2020 for this NDS. The sponsor submitted a Response to NOD (R-NOD) within 90 calendar days. Upon review of the R-NOD, considering the uncertainties regarding the clinical effectiveness and safety of Mar-treosulfan, its overall benefit-harm-uncertainty ratio for the proposed ovarian cancer indication and conditions of use was deemed not favorable.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
Prior to the submission of this NDS, 14 to 40 authorizations/years were granted for treosulfan through the Special Access Program (SAP) between 2015 and 2019. None of those requests were for the proposed indication (i.e., treatment of ovarian cancer), but rather, were for allogenic stem cell transplantation (SCT), as a conditioning agent prior to SCT, or for allogenic bone marrow transplantation therapy. The SAP requests do not suggest that there is a need for use of Mar-treosulfan as a treatment for patients with ovarian cancer in Canada. The cancellation of this NDS is not expected to lead to negative consequences for patients accessing the drug under SAP or via clinical trials.
Manufacturer:
Marcan Pharmaceuticals Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2019-08-30