AbbVie has been granted marketing authorisation by the European Commission for its FRα-directed ADC, Elahere.
The injectable cancer therapeutic, otherwise called mirvetuximab soravtansine, can now be distributed to adult patients with FRα+, platinum-resistant, ovarian, fallopian tube or primary peritoneal cancer.
It has been recommended for use in patients who have already received one, two or three prior systemic treatment regimens.
Elahere is the first and only ADC to target FRα that has gained approval from the European Union.
The EC's decision was based on the results of the Phase III MIRASOL trial, which highlighted Elahere's potential to reduce the risk of disease progression or death by 35% compared with chemotherapy.
Overall survival (OS) was also improved by the drug, as patients given Elahere experienced a 33% reduction in their risk of death compared with the chemotherapy cohort.
Adverse reactions included blurred vision, nausea, fatigue, diarrhoea, keratopathy, abdominal pain, constipation, vomiting, decreased appetite, headache, asthenia, arthralgia and — in some cases — penumonitis.
"It's been 10 years since a new treatment for platinum-resistant ovarian cancer was approved in the EU, and now oncologists have an effective, new, targeted treatment option for these patients," said Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven.
"Ovarian cancer can be devastating, taking women away from precious moments with their family, disrupting careers and the many other important contributions that women make to society," said Clara Mackay, CEO, World Ovarian Cancer Coalition. "In Europe, ovarian cancer is three times more deadly than breast cancer, and having new innovative options allows us to work toward a world where everyone living with ovarian cancer has the best chance of survival and the best quality of life possible, no matter where they live."
"The approval of ELAHERE by the European Commission provides a much needed clinically meaningful option for patients who receive the heartbreaking news their ovarian cancer has returned, fearing what's next in their treatment journey after they've developed platinum-resistance," said Roopal Thakkar, Executive VP of R&D and Chief Scientific Officer of AbbVie.
[Image credit: drugs.com]