AbbVie’s Elahere gets positive CHMP opinion for ovarian cancer treatment

USA—AbbVie has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for the marketing authorisation of mirvetuximab soravtansine, also known as Elahere.

 This drug is a first-in-class antibody-drug conjugate (ADC) that combines a folate receptor-alpha binding antibody, a cleavable linker, and the maytansinoid payload DM4—a potent tubulin inhibitor—designed to target and kill cancer cells specifically.

Elahere is intended for use in adult patients with folate receptor-alpha (FRα)-positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

These patients are typically those who have undergone one to three prior treatment regimens and are resistant to platinum-based therapies.

Ovarian cancer patients, in particular, often face challenges as their disease progresses, making this positive opinion from CHMP a promising step forward.

CHMP’s recommendation is based on the Phase 3 MIRASOL clinical trial findings, which provided strong evidence supporting the drug’s efficacy.

The European Commission’s final decision on the marketing authorization of mirvetuximab soravtansine in Europe is expected later this year.

Elahere received full FDA approval in the United States in March 2024, with submissions for marketing authorization currently under review in several other countries, reflecting the global potential of this innovative treatment.

Ovarian cancer remains one of the most challenging gynecological cancers to treat.

Patients are often diagnosed at an advanced stage, undergo surgery, and are treated primarily with platinum-based chemotherapy.

However, many patients eventually develop resistance to this treatment, requiring alternative therapeutic options.

Mirvetuximab soravtansine presents a new possibility for those who have developed platinum resistance, a critical area of unmet medical need.

Standard therapies in this setting, such as single-agent chemotherapies, have limited effectiveness and are often poorly tolerated by patients.

In a statement, AbbVie’s executive vice president of research and development and chief scientific officer, Dr. Roopal Thakkar, expressed optimism about the drug’s future in Europe.

He emphasized that years of development by ImmunoGen, now part of AbbVie, have led to this significant milestone.

Dr. Thakkar highlighted the importance of addressing the needs of patients with platinum-resistant ovarian cancer, whose treatment options are currently limited.

Ovarian cancer is one of the most common cancers affecting women globally.

 The World Cancer Research Foundation lists it as the 18th most common cancer worldwide and the 8th most common in women.

According to the World Ovarian Cancer Coalition, over 320,000 women were diagnosed with ovarian cancer in 2022.

This figure is projected to rise by 55% by 2050, reaching nearly half a million cases annually.

The majority of patients present with late-stage disease, where the cancer is more challenging to treat, and patients often relapse after standard treatments, highlighting the need for innovative therapies like Elahere to improve outcomes for these individuals.

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