NICE Final Draft Guidance recommends ELAHERE®▼ (mirvetuximab soravtansine), marking the first new treatment recommendation in 20 years for eligible adult patients with platinum-resistant ovarian cancer

MAIDENHEAD, UK, 04 June 2026 – AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has recommended ELAHERE® (mirvetuximab soravtansine) as a monotherapy treatment option for eligible adults with folate receptor-alpha (FRα) positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three lines of systemic treatment, in its Final Draft Guidance (FDG).¹ This recommendation marks an important step forward in the treatment of PROC, where there has been no advancement in access to innovative treatments in 20 years.^2,3

Across the UK, more than 40,000 women are living with ovarian cancer, and each year over 6,000 more women in England and Wales are diagnosed. ^{7, 8} In England and Wales, two thirds of people living with ovarian cancer are diagnosed late at stage 3 or 4, when the cancer is difficult to treat.⁷

PROC is the term used when the cancer progresses or recurs within six months of completing treatment with a platinum-based chemotherapy and it is estimated that up to 70% of patients will eventually relapse and become platinum resistant over time.^4, 5 PROC is severe and debilitating, with median overall survival being approximately one year. ^{3, 4} This makes people living with PROC one of the most underserved groups in ovarian cancer, facing limited options, high relapse rates, and poor outcomes.^{2, 9, 11}

“For those with FRa-positive platinum-resistant ovarian cancer, 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 twenty 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,” said Victoria Clare, Chief Executive Officer, Ovacome.

The NICE FDG recommendation is based on data from MIRASOL; a global phase 3, open-label, randomised, controlled trial.⁶ In MIRASOL, the median progression free survival (PFS, the primary endpoint of the trial) for patients who received mirvetuximab soravtansine  (n=227) was 5.62 months compared with 3.98 months for those who received chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan)  (n=226) [HR 0.65, 95% CI 0.521-0.808, p<0.001].⁶ Overall survival (a secondary endpoint) was significantly longer for those patients who received mirvetuximab soravtansine than those who received chemotherapy (median, 16.46 months vs. 12.75 months; HR 0.67; 95% CI, 0.50-0.89; P=0.005).⁶ This is the first time a significant benefit in both PFS and OS has been demonstrated in FRa-positive PROC for over two decades.

“NICE’s recommendation of mirvetuximab soravtansine is an important milestone, helping to ensure eligible women with FRα-positive platinum resistant ovarian cancer can access this therapy. For the first time in over twenty years, this new treatment offers the potential to extend survival where effective options have been limited. Mirvetuximab soravtansine is designed to target and help kill cancer cells expressing high levels of a biomarker called folate receptor. Having access to novel treatments such as mirvetuximab soravtansine, is vital, offering patients more options where few have existed and supporting a more tailored approach to care for ovarian cancer patients,” said Professor Susana Banerjee, UK lead for the MIRASOL trial, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, London and Professor in Women’s Cancers, the Institute of Cancer Research, London.

Mirvetuximab soravtansine is a targeted antibody-drug conjugate (ADC) for cancers that express high levels of a protein on the surface of cancer cells known as folate receptor alpha (FRα). The FRα protein is a biomarker that is commonly overexpressed on ovarian tumours and minimally expressed on normal tissues.⁶ FRα acts as a biomarker, meaning it provides biological information about the tumour that helps to determine whether certain therapies are likely to be effective. ⁷ Mirvetuximab soravtansine may stop the cancer cells from growing and can help to stop the disease from spreading.¹²

Roughly 80% of recurrent epithelial ovarian cancer has FRα on the surface of its cancer cells, and approximately 32%-36% of ovarian cancer cells have FRα-high expression.^{6, 14, 15} Biomarker testing is becoming an important part of modern cancer care, as it identifies changes in tumour genes and proteins, such as FRα, that influence how a cancer behaves and may respond to certain treatments.¹⁶ To determine if people are eligible for treatment with mirvetuximab soravtansine, a test must be done to assess FRα biomarker status. This can be done at diagnosis, relapse, or at the first sign of resistance to platinum-based chemotherapy.¹⁷

“NICE’s Final Draft Guidance (FDG) positive recommendation of mirvetuximab soravtansine is an important milestone for people living with platinum‑resistant ovarian cancer, an area of significant unmet need. As the first FRα biomarker‑targeted therapy for this population, we remain committed to working with healthcare authorities to help ensure eligible patients across the UK can access mirvetuximab soravtansine.” said Rachael Millward, Medical Director, AbbVie UK.

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UK media contact:

Rachael Pink
AbbVie UK
T: +44 (0)7816 180 570
E: [email protected]  

NOTES TO EDITORS:

About Ovarian Cancer
Ovarian cancer is caused by cells in the ovaries dividing uncontrollably, forming a tumour and potentially spreading to surrounding tissues or other parts of the body. ¹⁸ There are different types of ovarian cancer, depending on the type of cell it starts in these include, but are not limited to: epithelial ovarian cancers, germ cell ovarian cancer and sex cord stromal cancers.¹⁸ Across the UK, more than 40,000 women are living with ovarian cancer, and each year over 6,000 more women in England and Wales are diagnosed.^7,8

About ELAHERE® (mirvetuximab soravtansine)
Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate (ADC) composed of a folate receptor alpha binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.¹³

Mirvetuximab soravtansine received marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2025. ¹⁹ It was licensed by the European Commission in November 2024,²⁰ and also granted full FDA approval in the United States in March 2024.²¹

Marketing authorisation submissions for mirvetuximab soravtansine are under review in multiple other countries.

Safety profile¹⁹
The most common adverse reactions with mirvetuximab soravtansine were blurred vision, nausea, diarrhoea, fatigue, abdominal pain, keratopathy, dry eye, constipation, vomiting, decreased appetite, peripheral neuropathy, headache, asthenia, increased aspartate aminotransferase, and arthralgia. The most commonly reported serious adverse reactions were pneumonitis, small intestinal obstruction, intestinal obstruction, pleural effusion, abdominal pain, dehydration, constipation, nausea, ascites and thrombocytopenia.

About the Phase 3 MIRASOL Trial⁶
MIRASOL is a global Phase 3 open-label, randomised, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine, administered once every 3 weeks as an intravenous infusion, with the investigator's choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum-resistant, high-grade serous epithelial ovarian cancer whose tumours express high levels of FRα (≥75% of cells with ≥2+ staining intensity), confirmed with a validated test. Participants had previously received one to three lines of prior systemic therapy. The primary endpoint was investigator-assessed progression-free survival (PFS). Key secondary endpoints included objective response rate (ORR) and overall survival (OS).

More information can be found on www.clinicaltrials.gov (NCT 04209855).

About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients living with difficult-to-treat cancers. Today, our expansive oncology portfolio is comprised of approved and investigational treatments across a range of cancer types in both blood cancers and solid tumours. We are evaluating more than 35 investigational medicines across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit www.abbvie.co.uk.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at abbvie.co.uk. Follow AbbVie | UK on LinkedIn and YouTube (@abbvie-uk)