Health Canada has approved AbbVie's antibody-drug conjugate (ADC), Elahere (mirvetuximab soravtansine for injection), to treat adults with certain types of ovarian cancer.
This ADC is intended for folate receptor-alpha (FRα) positive, fallopian tube, platinum-resistant epithelial ovarian, or primary peritoneal, cancer.
The approval is specifically for those who have previously undergone one to three systemic treatment regimens.
Elahere is the only Health Canada-endorsed ADC that targets FRα. It is composed of a cleavable linker, an FRα-binding antibody and the maytansinoid payload DM4.
The approval was expedited through Health Canada’s priority review process, based on outcomes from the randomised MIRASOL Phase III trial.
This study is designed to evaluate the ADC’s safety and efficacy in comparison to the investigator's choice of standalone chemotherapy.
To qualify for the MIRASOL trial, subjects with platinum-resistant ovarian cancer (PROC) had to exhibit elevated FRα levels in their tumours, verified through the Ventana FOLR1 RxDx assay.
A total of 453 subjects were enrolled in the study, which had progression-free survival (PFS) as its primary endpoint.
Key secondary goals included overall survival (OS) and objective response rate (ORR).
The trial demonstrated a 33% statistically significant decrease in the mortality risk for those treated with Elahere, as indicated by an OS hazard ratio of 0.67 when compared to the chemotherapy arm.
AbbVie Canada general manager and vice-president Rami Fayed stated: “This new treatment is the first in over a decade for this type of ovarian cancer and marks a major milestone for patients.
“We take seriously our responsibility to research, develop and introduce therapies that impact patients’ lives, and AbbVie is committed to developing treatments for hard-to-treat cancers to help improve patients’ outcomes and quality of life.”
Health Canada recently issued a Notice of Compliance (NOC) to AbbVie’s Rinvoq (upadacitinib) for adults with giant cell arteritis (GCA).
