AbbVie has announced that the US Food and Drug Administration (FDA) has granted full approval to Elahere (mirvetuximab soravtansine-gynx) to treat certain ovarian cancer patients.
The antibody-drug conjugate (ADC), which was first approved in November 2022 under the FDA’s accelerated approvals pathway, can be used to treat adults with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Eligible patients will also have received one to three prior therapies.
The FDA’s initial approval of the drug, which AbbVie gained access to earlier this year through its $10.1bn acquisition of ImmunoGen, was based on positive results from the single-arm SORAYA trial in 106 patients with platinum-resistant ovarian cancer.
Elahere demonstrated an overall response rate of 31.7%, including five complete responses, and a median duration of response of 6.9 months.
The regulator’s latest decision was supported by the confirmatory late-stage MIRASOL trial, in which Elahere demonstrated a 33% reduction in risk of death and a 35% reduction in the risk of tumour or cancer progression compared to investigator’s choice chemotherapy.
Kathleen Moore, MIRASOL principal investigator, of the University of Oklahoma, outlined: “As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, Elahere provides an effective new option for patients with folate receptor alpha-positive tumours.”
Ovarian cancer is the leading cause of death from gynaecological cancers in the US, with approximately 20,000 people diagnosed with the disease each year.
The majority of patients present with late-stage disease and will usually undergo surgery followed by platinum-based chemotherapy. However, most will eventually develop platinum-resistant disease, at which point standard-of-care single-agent chemotherapies are associated with low response rates, short durations of response and significant toxicities.
Roopal Thakkar, senior vice president, chief medical officer, global therapeutics at AbbVie, said: “The full FDA approval of Elahere for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team.
“Elahere is the first and only ADC approved in the US for this difficult-to-treat malignancy.”
Beyond Elahere, ImmunoGen’s portfolio included an anti-CD123 ADC in mid-stage development for blastic plasmacytoid dendritic cell neoplasm, a rare blood cancer, and a phase 1 anti-FR-alpha ADC for ovarian cancer with the potential for expansion into other solid tumour indications.