The European Commission (EC) has granted marketing authorisation to AbbVie’s Elahere (mirvetuximab soravtansine) for the treatment of folate receptor-alpha (FRα) platinum-resistant ovarian cancer, a decade since the approval of the latest treatment.
Antibody-drug conjugate (ADC) Elahere has received European approval for the treatment of adult patients with FRα positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancers. The therapy is authorised for patients who have undergone one to three prior systemic treatment regimens.
Approximately 35%-40% of ovarian cancer patients express FRα, a biomarker specifically targeted by Elahere. By delivering the cytotoxic agent DM4 directly to cancer cells while sparing healthy tissue, the treatment aims to minimise off-target effects and reduce toxicity compared to traditional chemotherapy.
Elahere’s approval is supported by data from the Phase III MIRASOL trial (NCT04209855), which enrolled 453 patients with FRα-positive platinum-resistant ovarian cancer. The treatment demonstrated a significant and clinically meaningful 35% reduction in the risk of disease progression or death, compared to standard chemotherapy.
Patients treated with Elahere had a median progression-free survival (PFS) of 5.6 months, slightly longer than the four months observed in patients who received standard chemotherapy. Moreover, patients in the Elahere arm showed a median overall survival (OS) of 16.5 months while those in the investigator’s choice chemotherapy arm had a median OS of 12.8 months.
The approval of Elahere addresses an unmet need for patients with platinum-resistant ovarian cancer.
“It's been ten years since a new treatment for platinum-resistant ovarian cancer was approved in the EU, and now oncologists have an effective, new, targeted treatment option for these patients,” said Toon Van Gorp, professor of gynaecological oncology at the University of Leuven.
AbbVie inherited Elahere as part of a $10.1bn acquisition of ImmunoGen. The drug received accelerated approval by the US Food and Drug Administration (FDA) in November 2022 and was granted full FDA approval in the US in March 2024.
GlobalData market analysts predict that Elahere could generate up to $1.98bn in revenue for AbbVie by 2030. As the first FRα-targeted ADC approved in the EU, Elahere represents a competitive advantage for AbbVie in the ovarian cancer treatment landscape.
GlobalData is the parent company of Pharmaceutical Technology.
Elahere faces competition from Bristol Myers Squibb and Eisai’s ADC farletuzumab ecteribulin, which is currently being investigated in Phase II trials. However, Elahere holds the first-to-market advantage.
The drug is currently being investigated in three other ovarian cancer trials, in combination with Roche’s Avastin (bevacizumab) in the Phase III GLORIOSA study (NCT05445778), as a monotherapy in the Phase II PICCOLO study (NCT05041257), and with carboplatin in another Phase II trial (NCT05456685).
