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Marketing Approval Granted by MHRA for AbbVie's ELAHERE

AbbVie receives marketing approval for ELAHERE from the MHRA, and Med-Tech Insights conducts an interview with the company for further details.

Marketing Authorisation Granted by MHRA for AbbVie's ELAHERE
Marketing Authorisation Granted by MHRA for AbbVie's ELAHERE

Marketing Approval Granted by MHRA for AbbVie's ELAHERE

New Treatment Option for Ovarian Cancer in the UK: Mirvetuximab Soravtansine

Mirvetuximab soravtansine, marketed as ELAHERE®, has recently received marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of platinum-resistant ovarian cancer in eligible adult patients with high folate receptor-alpha (FRα) expression. However, its availability on the National Health Service (NHS) in England and Scotland is still under review by the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC).

AbbVie, the manufacturer of mirvetuximab soravtansine, is currently going through the submission process with both NICE and the SMC. The company is working diligently to complete the appraisal process as efficiently as possible. It's important to note that individual patients must speak with their clinicians for further guidance regarding the global patient access scheme that AbbVie has in place for this medication.

The ongoing clinical study assessing the safety and efficacy of mirvetuximab soravtansine started in May 2025 and is expected to complete in 2027. This timeline is also a factor in the NICE appraisal considerations. While the drug is licensed for use, routine access via the NHS in England may not yet be established.

The speed of access to mirvetuximab soravtansine is considered vital for eligible women with platinum-resistant ovarian cancer (PROC) in the UK. The outcome and recommendations from NICE's appraisal process will likely determine when the treatment will be available to eligible patients on the NHS.

The approval of mirvetuximab soravtansine provides a new treatment option for eligible people living with this type of ovarian cancer in the UK. It's hoped that, following a successful appraisal by NICE and the SMC, the treatment will become widely available on the NHS, offering hope to many patients.

[1] AbbVie. (2025). AbbVie announces European Commission approval of mirvetuximab soravtansine for the treatment of platinum-resistant ovarian cancer. Retrieved from https://www.abbvie.com/news/press-releases/2025/abbvie-announces-european-commission-approval-of-mirvetuximab-soravtansine-for-the-treatment-of-platinum-resistant-ovarian-cancer.html

[2] National Institute for Health and Care Excellence. (2025). Mirvetuximab soravtansine for the treatment of platinum-resistant ovarian cancer. Retrieved from https://www.nice.org.uk/guidance/indevelopment/gid-ta10409

[3] Scottish Medicines Consortium. (2025). Mirvetuximab soravtansine for the treatment of platinum-resistant ovarian cancer. Retrieved from https://www.scottishmedicines.org.uk/medicines-a-to-z/m/mirvetuximab-soravtansine/

[1] The approval of mirvetuximab soravtansine by the UK's Medicines and Healthcare products Regulatory Agency for treating platinum-resistant ovarian cancer marks a significant breakthrough in women's health and health-and-wellness.

[2] As clinical trials for mirvetuximab soravtansine continue, with the study expected to complete in 2027, womens-health advocates are closely watching the progress of the treatment's approval by both the National Institute for Health and Care Excellence and the Scottish Medicines Consortium.

[3] Science has made strides in the field of femtech news, with the new treatment option for ovarian cancer, mirvetuximab soravtansine, posing potential solutions for patients battling ovarian cancer, particularly those with medical-conditions like platinum-resistant ovarian cancer.

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