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news.The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AbbVie’s mirvetuximab soravtansine in adults with a specific type of ovarian cancer.
The European Commission is expected to make a regulatory decision on this indication for mirvetuximab soravtansine later in the year. Credit: National Cancer Institute on Unsplash.
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The treatment targets those with folate receptor alpha (FRα)-positive, platinum-resistant, and high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have undergone one to three treatment regimens previously.
An antibody-drug conjugate (ADC), mirvetuximab soravtansine includes a folate receptor-alpha binding antibody, a cleavable linker, and the maytansinoid payload DM4, which inhibits tubulin to eliminate targeted cancer cells.
The CHMP’s positive opinion is based on the results of the Phase III MIRASOL clinical trial.
This global, open-label, randomised, controlled study enrolled 453 patients to assess the efficacy and safety of mirvetuximab soravtansine versus investigator’s choice of single-agent chemotherapy in patients with platinum-resistant, high-grade serous ovarian cancer expressing high levels of FRα.
Progression-free survival (PFS) was the trial’s primary endpoint.
Key secondary endpoints included the objective response rate (ORR) and overall survival (OS).
The European Commission is expected to make a regulatory decision on this indication for mirvetuximab soravtansine later in the year.
In the US, mirvetuximab soravtansine-gynx, branded as ELAHERE, received full approval from the FDA in March this year.
Marketing authorisation submissions of the company for mirvetuximab soravtansine are currently under review in several other countries.
AbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar said: “Following many years of development by the ImmunoGen team that is now part of AbbVie, we are hopeful to make mirvetuximab soravtansine available to eligible patients with ovarian cancer in the European Union.
“This positive opinion recognises the unmet need for certain patients with platinum-resistant ovarian cancer.”
