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June 20, 2018

FDA fast-tracks ImmunoGen’s treatment for ovarian cancer

US Food and Drug Administration (FDA) has awarded Fast Track designation to ImmunoGen’s lead programme mirvetuximab soravtansine for patients with platinum-resistant ovarian cancer.

US Food and Drug Administration (FDA) has awarded Fast Track designation to ImmunoGen’s lead programme mirvetuximab soravtansine for patients with platinum-resistant ovarian cancer.

The designation is for patients suffering from medium to high folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer and who have received at least one and no more than three prior systemic treatment regimens and are eligible to undergo single-agent chemotherapy.

ImmunoGen president and CEO Mark Enyedy said: “Patients with platinum-resistant ovarian cancer have a poor prognosis and we are encouraged by the FDA’s recognition of the significant need for new therapeutic options that may be addressed by mirvetuximab as monotherapy.

“This important designation is based on the promising safety and activity findings observed to-date and we look forward to working closely with the FDA as we advance the development of mirvetuximab.”

“We are encouraged by the FDA’s recognition of the significant need for new therapeutic options for platinum-resistant ovarian cancer.”

This fast track designation will expedite development and the subsequent assessment process so that the mirvetuximab soravtansine can be commercialised at the earliest.

Mirvetuximab soravtansine utilises a humanised FRα-binding antibody to target the antibody-drug conjugates (ADC) specifically to FRα-expressing cancer cells and potential anti-tumour agent DM4, eliminating targeted cancer cells.

Currently, the drug is being assessed in the FORWARD I Phase 3 trial, which includes 333 patients segregated in 2:1 ratio to be administered with mirvetuximab soravtansine or with the physician’s choice of single-agent chemotherapy.

The primary endpoint of the study is Progression Free Survival and will be evaluated upon the overall study population.

ImmunoGen aims to report top-line results from the FORWARD I trial in the first half of next year.

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