UK MHRA green lights AbbVie’s ELAHERE for ovarian cancer

News

AbbVie has secured UK marketing authorisation for ELAHERE (mirvetuximab soravtansine), the first antibody-drug conjugate (ADC) approved in the country for treating folate receptor-alpha (FRα) high, platinum-resistant ovarian cancer.

The authorisation, granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA), covers use of the drug as a monotherapy in adults with FRα-high, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, following one to three prior lines of systemic treatment.

Mirvetuximab soravtansine is the first new treatment to be licensed in the UK for this indication in over a decade.

“This is a milestone for the treatment of eligible adult women with folate-receptor high platinum-resistant ovarian cancer in the UK,” said Professor Susana Banerjee, consultant medical oncologist at The Royal Marsden NHS Foundation Trust and Reader in Women’s Cancers at The Institute of Cancer Research, London. “Treatment advances with novel mechanisms of action, like mirvetuximab soravtansine, are crucial for helping eligible women with this type of cancer.”

Ovarian cancer is one of the leading causes of death from gynaecological cancer worldwide. In the UK, there are around 7,500 new diagnoses each year, making it the sixth most common cancer in women. Standard treatment typically involves surgery followed by platinum-based chemotherapy, but around 80% of patients with advanced disease relapse. Most eventually develop resistance to platinum therapy.

ELAHERE is administered once every three weeks and is the first new treatment licensed in the UK in over a decade for women with platinum-resistant ovarian cancer. The targeted ADC delivers a cytotoxic payload directly to FRα-expressing tumour cells, aiming to minimise damage to healthy tissues.

The MHRA’s decision was supported by data from the MIRASOL trial, a global Phase 3, open-label, randomised controlled study that evaluated mirvetuximab soravtansine in patients with FRα-high, platinum-resistant ovarian cancer. Results from the study showed that median progression-free survival (PFS) – the trial’s primary endpoint – was 5.62 months in the mirvetuximab group compared to 3.98 months in the chemotherapy group. This translated to a 35% reduction in the risk of disease progression or death.

“AbbVie has an established portfolio of licensed therapies across blood cancers, and today’s announcement marks our broader commitment to support treatment outcomes for patients with solid tumours,” said Rachael Millward, Medical Director, AbbVie UK. “This is an important development for women with advanced ovarian cancer, and in particular, the underserved platinum-resistant patient population. Following marketing authorisation, our priority now is to work with NICE to provide all the necessary information for their appraisal of mirvetuximab soravtansine.”