Authorization Granted: AbbVie secures marketing approval from MHRA for ELAHERE
New Treatment Option for Ovarian Cancer: Mirvetuximab Soravtansine Approved by MHRA
Mirvetuximab soravtansine, marketed as Elahere, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with ovarian, fallopian tube, and primary peritoneal cancer. This approval marks a significant step in the fight against ovarian cancer, offering a new treatment option for eligible individuals in the UK.
The drug, which targets the folate receptor-alpha (FRα), is licensed as a monotherapy in the UK for patients who have previously not responded to or are no longer responding to platinum-based chemotherapy and have high levels of FRα. Mirvetuximab soravtansine is currently approved for use in adults with platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
The speed of access to this new treatment for eligible women with ovarian cancer in the UK is considered vital. However, it is important to note that while the MHRA has approved mirvetuximab soravtansine, its reimbursement and availability within the NHS are yet to be determined by the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC).
AbbVie, the manufacturer of mirvetuximab soravtansine, has a global patient access scheme in place, and individual patients should speak with their clinicians for further guidance. The company is currently going through the submission process with both NICE and the SMC, aiming to provide robust evidence for both appraisal bodies.
In addition to its use as a monotherapy, mirvetuximab soravtansine is being evaluated for use in patients with FRα medium expressors. The ongoing development program for mirvetuximab soravtansine includes studies in the monotherapy setting, as well as evaluations in combination with other therapies. Clinical trials are underway to explore the use of mirvetuximab soravtansine in combination therapy for ovarian cancer.
The evaluations of mirvetuximab soravtansine are being conducted in both the second line plus platinum-sensitive and first-line maintenance settings. This means that the drug is being considered for use not only in advanced stages of the disease but also in earlier stages, potentially offering hope to a wider range of patients.
For the most accurate and up-to-date information on the NICE and SMC appraisals for mirvetuximab soravtansine, it is advisable to check the official NICE and SMC websites for ongoing appraisals. As these appraisals are crucial for determining the drug's availability within the NHS and its reimbursement, they are eagerly awaited by both patients and healthcare professionals.
