The Food and Drug Administration (FDA) has granted Fast Track designation to mirvetuximab soravtansine (ImmunoGen), for patients with medium to high folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer who have received ≥1 but no more than 3 prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line therapy.

Mirvetuximuab soravtansine uses a humanized FRα-binding antibody to target antibody-drug conjugates specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells. The treatment is being evaluated in the FORWAD I Phase 3 trial which has enrolled 333 patients with platinum-resistant ovarian cancer with medium to high FRα expression. Patients are being randomized 2:1 to either mirvetuximab soravtansine or a physician’s choice of single-agent chemotherapy. The Company expects to have the top-line results from the trial in the first half of 2019. 

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“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,” said Mark Enyedy, ImmunoGen’s president and CEO. 

In addition, the FORWARD II study is assessing mirvetuximab soravtansine as a combination treatment with bevacizumab or pembrolizumab in patients with FRα-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, and as a triple therapy with carboplatin and bevacizumab in patients with platinum-sensitive ovarian cancer. 

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