This decision was issued under CDA-AMC’s Target Zero initiative, a program designed to accelerate patient access to promising new therapies by removing delays between Health Canada approval and reimbursement recommendations to participating public drug plans. As part of this initiative, mirvetuximab soravtansine was submitted for review 180 days prior to Health Canada’s regulatory decision, enabling CDA-AMC to issue a reimbursement recommendation immediately following approval.
On September 2, 2025, Health Canada approved mirvetuximab soravtansine for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic regimens.2 The approval was supported by results from the phase 3 MIRASOL trial (NCT04209855), in which treatment with mirvetuximab soravtansine significantly improved outcomes vs investigator’s choice of chemotherapy, demonstrating a 42% overall response rate (ORR) vs 16% with chemotherapy, including a 5% complete response rate vs 0%, respectively. The trial also revealed statistically significant improvements in overall survival (OS; HR, 0.67; 95% CI, 0.50-0.88; P = .0046) and progression-free survival (PFS) (HR, 0.65; 95% CI, 0.52-0.81; P < .0001).
"This treatment represents a positive step forward in bringing better outcomes to people living with hard-to-treat ovarian cancers," Shannon Salvador, MD, associate professor at McGill University and the president-elect of the Society of Gynecologic Oncology of Canada, shared in a news release.1 "But innovation only matters if it's accessible to patients. I am encouraged to see the reimbursement recommendation from the CDA-AMC, made possible through the parallel review that took place as a result of the Target Zero initiative."
What was the design of the MIRASOL trial?
The phase 3 MIRASOL trial was a randomized study designed to evaluate the efficacy and safety of mirvetuximab soravtansine compared with investigator’s choice of single-agent chemotherapy in patients with platinum-resistant advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer.3
Eligible patients had tumors positive for FRα, defined as at least 75% of tumor cells staining at ≥2+ intensity, confirmed by central laboratory testing. A total of 453 patients were enrolled and randomly assigned to receive either mirvetuximab soravtansine or chemotherapy. The primary end point was PFS by investigator assessment, with key secondary end points including ORR and OS.
Data from this study also supported the March 2024 full FDA approval of mirvetuximab soravtansine-gynx for adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have previously received one to three systemic treatment regimens.4
What is known about mirvetuximab soravtansine’s safety profile?
Regarding safety, in the MIRASOL trial, serious adverse effects (AEs) occurred in 24% of patients treated with mirvetuximab soravtansine.2 The most frequent serious AEs, each reported in at least 2% of patients, included pleural effusion (3%), abdominal pain (3%), intestinal obstruction (2%), ascites (2%), and small intestinal obstruction (2%).
“CDA-AMC's positive reimbursement recommendation for [mirvetuximab soravtansine] represents the first new treatment option in Canada for hard-to-treat platinum-resistant ovarian cancers in over 10 years. This recommendation not only addresses a significant challenge in the treatment of ovarian cancer, it offers real hope to the women diagnosed with this disease," Tania Vrionis, chief executive officer of Ovarian Cancer Canada, added in a news release.1 "Time is of the essence for our patient community, and we are encouraged to see CDA-AMC's commitment to accelerating how quickly they can access innovative treatments."
References
- Elahere receives positive reimbursement recommendation by Canada’s Drug Agency for certain types of platinum-resistant ovarian cancer. AbbVie. News Release. October 31, 2025. Accessed October 31, 2025. https://www.biospace.com/press-releases/elahere-receives-positive-reimbursement-recommendation-by-canadas-drug-agency-for-certain-types-of-platinum-resistant-ovarian-cancers
- Health Canada approves Elahere® for certain types of platinum-resistant ovarian cancers. News Release. AbbVie. September 2, 2025. Accessed October 31, 2025. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/press-releases/ELAHERE-press-release-EN.pdf
- A study of mirvetuximab soravtansine vs. investigator's choice (IC) of chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha (frα) expression (MIRASOL). Clinicaltrials.gov Updated August 27, 2025. Accessed October 31, 2025. https://www.clinicaltrials.gov/study/NCT04209855
- FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. FDA. Accessed March 22, 2024. Accessed October 31, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant-epithelial-ovarian
