ELAHERE® Receives Positive Reimbursement Recommendation by Canada's Drug Agency for Certain Types of Platinum-Resistant Ovarian Cancers

• ELAHERE^® receives a positive recommendation by Canada's Drug Agency (CDA-AMC)
• ELAHERE^® was submitted for reimbursement review 180 days prior to Health Canada's approval in line with CDA-AMC's new Target Zero initiative

Today, AbbVie (NYSE: ABBV) has announced that Canada's Drug Agency (CDA-AMC), formerly CADTH, has recommended that ELAHERE® (mirvetuximab soravtansine for injection), an antibody-drug conjugate (ADC), be reimbursed with conditions, for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.1

As part of CDA-AMC's Target Zero initiative—designed to accelerate patient access to promising new treatments by removing delays between Health Canada approval and CDA-AMC's reimbursement recommendation to participating public drug plans²—ELAHERE^® was submitted for reimbursement review 180 days prior to Health Canada's approval³, which has resulted in a positive reimbursement recommendation for patients living with certain types of platinum-resistant ovarian cancer, a disease with the lowest survival rate among gynecological cancers in Canada.⁴ The Target Zero initiative represents a meaningful step towards faster access to innovative new treatment options.

"CDA-AMC's positive reimbursement recommendation for ELAHERE^® 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," said Tania Vrionis, CEO of Ovarian Cancer Canada, the only national health charity focused on supporting Canadians facing ovarian cancer. "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."

"This treatment represents a positive step forward in bringing better outcomes to people living with hard-to-treat ovarian cancers," said Dr. Shannon Salvador, Associate Professor at McGill University and the President of the Society of Gynecologic Oncology of Canada. "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."

"Patients can only benefit from medicines if they can access it," said Rami Fayed, Vice President and General Manager of AbbVie Canada. "Target Zero represents a great example of collaboration across the approval of medicines in Canada's reimbursement landscape, helping to shorten the time it takes for patients to access new, proven therapies. We applaud CDA-AMC for their patient-focused approach—this is great news for Canadians. We look forward to working with the pCPA to ensure the next steps progress without delay so that women can access ELAHERE^® as soon as possible."

About the Phase 3 MIRASOL Trial
MIRASOL is a randomized Phase 3 trial evaluating the efficacy and safety of ELAHERE^® (mirvetuximab soravtansine for injection) versus investigator's choice (IC) of single-agent chemotherapy. Eligibility criteria included patients with platinum-resistant advanced epithelial ovarian, primary peritoneal or fallopian tube cancers patients whose tumours were positive for FRα as determined by the VENTANA FOLR1 (FOLR1- 2.1) RxDx Assay (≥ 75% of tumour staining at ≥ 2+ intensity) evaluated at a central laboratory. The trial enrolled 453 patients. The primary endpoint was progression-free survival (PFS) by investigator assessment, and key secondary endpoints included objective response rate (ORR) and overall survival (OS).

About Ovarian Cancer
Ovarian cancer is the leading cause of death from gynecological cancers in Canada.⁴ In 2024, an estimated 3,000 women were diagnosed.⁵ Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy.⁶ Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat.⁶ 

About ELAHERE^®
ELAHERE^® (mirvetuximab soravtansine) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE^® (mirvetuximab for injection) as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Please consult the ELAHERE^® Product Monograph at https://www.abbvie.ca/en/our-science/products.html.

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 35 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, gynecology and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Instagram, or LinkedIn.

References

SOURCE AbbVie Canada

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