ENGLAND — The National Institute for Health and Care Excellence approved mirvetuximab soravtansine for National Health Service use in England following a commercial agreement with AbbVie. The treatment will be available for up to 400 women per year in England who have platinum-resistant ovarian cancer.
Mirvetuximab soravtansine is indicated for patients with epithelial ovarian, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy and expresses the FR α protein. The drug is administered intravenously once every three weeks.
A global clinical trial conducted across eight NHS hospitals found the treatment prolonged average survival by four months compared to standard chemotherapy. Average survival was 16.5 months for patients receiving the drug and 12.8 months for those receiving standard chemotherapy. Tumors shrank by at least 30 percent in 37 percent of trial patients, compared with 16 percent in the chemotherapy group.
Ruth Plummer, NHS England national clinical lead for cancer drugs, said the approval represented a breakthrough in NHS treatment for these hard-to-treat ovarian cancers in over two decades. Mirvetuximab soravtansine contains an antibody designed to bind to the FR α protein on cancer cells, which delivers a cytotoxic agent directly to the tumor. The pharmaceutical company AbbVie developed and manufactures the treatment.
Helen Knight, director of medicines evaluation at NICE, said, "We heard clearly from patients and clinicians about the very limited options available at this stage of the disease and the substantial burden that chemotherapy places on women's lives. We are pleased that, following a robust process and a new commercial arrangement with AbbVie, we are now able to recommend this treatment for NHS use."
More than three-quarters of ovarian cancer patients are diagnosed at an advanced stage, and approximately 80 percent of those patients eventually develop resistance to chemotherapy. Rowan Miller, clinical trial lead at University College London Hospitals, said, "Finally, there is a drug that is available that improves survival for this group of patients, and in addition, the patients get on with the treatment well and find it easier to manage than standard chemotherapy."