Authorisation Granted: MHRA Approves AbbVie's Marketing for ELAHERE
The UK has approved a new treatment option for a certain type of ovarian cancer, with mirvetuximab soravtansine (Elahere) receiving conditional marketing authorization from the MHRA in late July 2025 [1][2][3][5]. This innovative cancer therapy, developed by AbbVie, targets folate receptor-alpha positive, platinum-resistant high-grade serous epithelial ovarian cancer in adult patients who have received one to three prior systemic treatment regimens [5].
However, the availability of mirvetuximab soravtansine on the NHS in England and Scotland remains pending, as the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) are yet to conduct their appraisals on the medicine [4].
While the MHRA's authorization allows regulatory marketing in the UK, the actual access to the treatment on the NHS will depend on the positive recommendations from NICE and SMC. The pace of these appraisals can vary, but it is expected that NHS availability may be expected later in 2025 or 2026, assuming positive recommendations [4].
AbbVie has a global patient access scheme in place for mirvetuximab soravtansine, and individual patients must consult with their clinicians for further guidance [6]. The company's policy on pre-approval access is designed to protect the fair, equitable, and uninterrupted access of unapproved medications while also protecting the integrity of ongoing clinical trials.
Ovarian cancer is one of the leading causes of death from gynaecological cancer in the UK. Most women with advanced ovarian cancer eventually develop resistance to treatment, resulting in a poor prognosis. Historically, limited treatment options have been available for patients with platinum-resistant ovarian cancer, often resulting in adverse events that negatively impact quality of life [7].
The ongoing development program for mirvetuximab soravtansine includes evaluating it in combination with other therapies, as well as for use in ovarian cancer beyond the monotherapy setting. Trials are also underway for the use of mirvetuximab soravtansine in the first-line maintenance setting, the second line plus platinum-sensitive setting, and for FRα medium expressors [8].
In summary, while mirvetuximab soravtansine is officially authorized in the UK, it is not yet routinely available on the NHS in England and Scotland until NICE and SMC complete their appraisals and endorse funding. This new treatment option offers hope for eligible people living with platinum-resistant ovarian cancer, and the results of ongoing trials will further expand its potential applications.
References:
- MHRA press release
- AbbVie press release
- Clinical trial information
- NICE and SMC appraisal status
- Summary of Product Characteristics (SmPC)
- AbbVie global patient access scheme
- Overview of ovarian cancer treatment
- Clinical trial information
