A new ovarian cancer drug offers hope to hundreds of women in England whose disease has stopped responding to chemotherapy, after the National Institute for Health and Care Excellence (Nice) approved it for NHS use in a landmark decision. The treatment, mirvetuximab soravtansine – sold as Elahere by developer AbbVie – is the first new ovarian cancer therapy to be made available on the health service in more than two decades, providing a lifeline for patients with advanced, hard-to-treat forms of the disease.
The drug has been recommended for adult patients with folate receptor-alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have already received one to three prior courses of systemic treatment. Platinum resistance occurs when the disease no longer responds to standard platinum-based chemotherapy, a situation that often coincides with late-stage diagnosis and severely restricted options. NHS England has said that up to 400 patients in England each year could benefit from the new therapy.
Nice’s final draft guidance follows a regulatory green light from the Medicines and Healthcare products Regulatory Agency (MHRA), which granted UK marketing authorisation on 24 July 2025 via the International Recognition Procedure. AbbVie plans to launch Elahere at a list price equal to that in the United States – £4,950 per 100-mg vial – and a new commercial arrangement with Nice, negotiated after the institute initially concluded the drug was not cost-effective, helped secure the final positive recommendation. A streamlined alignment pathway between the MHRA and Nice, launched in April 2026, is designed to accelerate patient access to such medicines.
How the therapy targets cancer cells
Mirvetuximab soravtansine is a precision medicine described by clinicians as a “biological missile” or “Trojan horse” therapy. It is a first-in-class antibody-drug conjugate (ADC) composed of three components: a monoclonal antibody that binds specifically to the folate receptor-alpha protein found on the surface of certain cancer cells; a cleavable molecular linker; and a potent chemotherapy payload called DM4, a maytansinoid that acts as a tubulin inhibitor. Once the antibody attaches to the FRα target on the tumour cell, the complex is internalised and the linker is cleaved, releasing DM4 inside the cell. The payload then disrupts the cell’s microtubule network, blocking division and triggering death – effectively destroying the cancer from within.
Targeting FRα is critical because the protein is widely expressed in many ovarian cancers. Research indicates that around 45% of gynaecological tumours carry FRα, with higher-grade serous ovarian cancers showing expression in approximately 54% of cases. Crucially, recurrent ovarian cancers exhibit FRα in about 82% of instances, making the marker an attractive target for women whose disease has relapsed. The drug is administered intravenously once every three weeks.
Clinical evidence shows survival benefit
Two key clinical trials underpin the approval. The phase 2 SORAYA study, a single-arm trial in patients with platinum-resistant ovarian cancer and high FRα expression who had received one to three prior therapies, met its primary endpoint with an objective response rate of 32.4%, including five complete responses and 29 partial responses. The median duration of response was 6.9 months. The phase 3 MIRASOL trial – a global, randomised, open-label study involving 453 patients with FRα-positive, high-grade serous ovarian cancer – then delivered further evidence. In its final analysis, presented at the 2025 Society of Gynecologic Oncology Annual Meeting, mirvetuximab soravtansine showed a median overall survival of 16.85 months compared with 13.34 months for the investigator’s choice of chemotherapy – a 32% reduction in the risk of death. Progression-free survival also improved, with a 37% reduction in the risk of progression or death. Tumour shrinkage of at least 30% was seen in 37% of patients receiving the new drug, versus 16% on chemotherapy. Overall, clinical trials have demonstrated that the drug extends survival by around four months on average compared with chemotherapy alone.
Professor Ruth Plummer, NHS England’s national clinical lead for cancer drugs, said: “This represents the most significant breakthrough in NHS treatment for these hard-to-treat ovarian cancers in over two decades – and we’re delighted it will now offer hundreds of women much-needed hope of precious extra time with their loved ones.”
Patient experiences: a new lease of life
Patricia Hill, a 64-year-old retired NHS physiotherapist from north London who began treatment with mirvetuximab in January this year, described how previous chemotherapy cycles left her bed-bound. “Previously, I’ve had three different lines of chemotherapy, and this is the first time that I’ve actually been able to get on with my life in terms of the impact of side effects,” she said. “The feelings of isolation and loneliness that you have undergoing conventional chemotherapy are totally or more or less totally eradicated when using mirvetuximab. It actually adds life to years, rather than spending your life in bed recovering from the side effects of chemotherapy.”
Another patient, Angela, who was diagnosed with stage 3 ovarian cancer and later became platinum-resistant, described the drug as a “lifeline” after her recurrence. Ovarian cancer is the sixth most common cancer in women in the UK, with around 7,700 new cases diagnosed each year. Over 50% of cases are detected at an advanced stage, and approximately 80% of patients with advanced disease relapse, with most eventually developing resistance to chemotherapy. Around 4,142 people die from the disease annually. Victoria Clare, chief executive of the charity Ovacome, said: “Today marks a landmark moment. Being told that platinum-based chemotherapy is no longer working can bring anxiety and uncertainty, particularly when the disease is at an advanced stage, where time and options are limited. This recommendation is the first in over 20 years to offer the ovarian cancer community an additional choice at a critical stage, with the potential to make a real difference to patients and their families.” Rachel Downing, head of policy and external affairs at Target Ovarian Cancer, added: “This is a hugely important moment for women with platinum-resistant ovarian cancer and their families, who have faced limited effective treatment options for far too long. Today’s announcement offers real hope of improved quality of life.”
Mirvetuximab soravtansine is not without side effects. Common adverse reactions include blurred vision, fatigue, nausea, diarrhoea, and changes in liver enzymes; it can also cause severe ocular toxicities such as keratopathy and photophobia, requiring ophthalmic examinations before and during treatment. In clinical trials, 12% of patients permanently discontinued the drug due to adverse reactions. 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.”