AbbVie receives marketing authorization from MHRA

AbbVie has announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for ELAHERE (mirvetuximab soravtansine) as monotherapy for the treatment of eligible adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

Ovarian cancer is one of the leading causes of death from gynaecological cancer worldwide. In the UK, there are around 7,500 new diagnoses of the disease each year, making it the sixth most common cancer in women. Unfortunately, two thirds of women with ovarian cancer are diagnosed late, when the cancer is harder to treat. Women newly diagnosed with ovarian cancer typically receive surgery and platinum-based chemotherapy, but sadly, 80% of people with advanced disease relapse and the majority eventually develop resistance to this treatment, resulting in poor prognosis.

Mirvetuximab soravtansine is the first new treatment in 10 years to be licensed for the treatment of women in the UK with platinum-resistant ovarian cancer and is administered once every 3 weeks. This authorisation is supported by data from MIRASOL; a global, Phase 3, open-label, randomised, controlled trial. In MIRASOL, the median progression free survival (PFS, the primary endpoint of the trial) for patients who received mirvetuximab soravtansine (n=227) was 5.62 months compared with 3.98 months for those who received chemotherapy (n=226) [HR 0.65, 95% CI 0.521-0.808, p<0.001]. This means that mirvetuximab soravtansine reduced the chance of the cancer progressing or the patient dying by 35% compared with those who received chemotherapy.

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