AbbVie’s Elahere (mirvetuximab soravtansine) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with ovarian, fallopian tube and primary peritoneal cancer.
The antibody drug conjugate (ADC) has been authorised for use as a monotherapy in patients whose cancer cells have a protein on the surface known as folate receptor-alpha (FRα), which is highly expressed in around one third of ovarian cancer patients.
Patients eligible for the drug will also have already received one to three prior systemic treatment regimens, and will have previously not responded to or are no longer responding to platinum-based chemotherapy.
Approximately 7,500 people are diagnosed with ovarian cancer every year in the UK, making it the sixth most common cancer in women.
Newly diagnosed patients usually receive surgery and platinum- based chemotherapy; however, 80% of those with advanced disease relapse and the majority eventually develop resistance to this treatment.
AbbVie’s Elahere, which the company gained access to last year through its $10.1bn acquisition of ImmunoGen, is designed to target and kill tumour cells that express high levels of FRα while reducing impact on healthy tissue.
The drug is administered once every three weeks as an intravenous infusion, and is now the first new treatment in ten years to be licensed in the UK for patients with platinum-resistant ovarian cancer.
Rachael Millward, medical director, AbbVie UK, said: “This is an important development for women with advanced ovarian cancer, and in particular the underserved platinum-resistant patient population.
“Following marketing authorisation, our priority now is to work with the National Institute for Health and Care Excellence (NICE) to provide all the necessary information for [its] appraisal of [Elahere].”
The MHRA’s decision was supported by results from the late-stage MIRASOL trial, in which median progression-free survival was 5.62 months for Elahere-treated patients and 3.98 months for those receiving investigator’s choice chemotherapy.
Median overall survival was also significantly longer for patients in the Elahere cohort compared to those who received chemotherapy, at 16.46 months versus 12.75 months.
Julian Beach, MHRA interim executive director, healthcare quality and access, said: “We are committed to making innovative treatment options, like [Elahere], the first and only FRα directed ADC, available to patients as quickly as possible, ensuring our approval is underpinned by robust evidence of efficacy alongside the highest standards of safety.”