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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.