European Commission approves AbbVie’s Elahere for platinum-resistant ovarian cancer 

UK—The European Commission (EC) has granted marketing authorization to AbbVie’s Elahere (mirvetuximab soravtansine), a novel therapy for platinum-resistant ovarian cancer, marking the first approval of its kind in the EU in over a decade.

This antibody-drug conjugate (ADC) offers new hope to patients with folate receptor-alpha (FRα)-positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancers.

The treatment is intended for adults who have undergone one to three prior systemic therapies. 

Approximately 35%-40% of ovarian cancer patients express FRα, a biomarker specifically targeted by Elahere.

Unlike traditional chemotherapy, which affects both healthy and cancerous cells, Elahere delivers the cytotoxic agent DM4 directly to cancer cells.

This targeted approach minimizes off-target effects, potentially reducing treatment-related toxicity and improving patients’ quality of life. 

The approval is based on robust results from the Phase III MIRASOL trial, which included 453 patients with FRα-positive, platinum-resistant ovarian cancer.

The study demonstrated that Elahere significantly reduced the risk of disease progression or death by 35% compared to standard chemotherapy.

Patients treated with Elahere achieved a median progression-free survival (PFS) of 5.6 months, surpassing the four months observed in the chemotherapy group.

Moreover, the median overall survival (OS) was particularly longer in the Elahere arm, at 16.5 months, compared to 12.8 months in the chemotherapy arm. 

Elahere’s approval addresses a critical unmet need in ovarian cancer care.

Professor Toon Van Gorp, a gynecological oncology expert from the University of Leuven, emphasized the significance of this milestone, stating that it has been ten years since a new treatment for platinum-resistant ovarian cancer was approved in the EU.

He highlighted that Elahere now offers oncologists a much-needed, effective, and targeted option for managing this challenging disease. 

AbbVie acquired Elahere through its US$10.1 billion acquisition of ImmunoGen and has already seen accelerated and full approvals for the drug in the United States.

 Analysts project that Elahere could generate up to US$1.98 billion in revenue by 2030, cementing its role as a cornerstone of AbbVie’s oncology portfolio. 

Although Elahere faces competition from Bristol Myers Squibb and Eisai’s farletuzumab ecteribulin, which is undergoing Phase II trials, it benefits from its first-to-market advantage.

Additionally, Elahere is being explored in three other ovarian cancer trials.

These include combinations with Roche’s Avastin in the Phase III GLORIOSA trial and carboplatin in a separate Phase II trial, as well as monotherapy in the Phase II PICCOLO study. 

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