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ImmunoGen's ovarian cancer drug gets US FDA fast-track designation

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ImmunoGen's ovarian cancer drug gets US FDA fast-track designation

ImmunoGen Inc. said the U.S. Food and Drug Administration granted fast-track designation to its experimental drug mirvetuximab soravtansine to treat a type of ovarian cancer.

The Waltham, Mass.-based company said the drug received the status to treat patients with folate receptor alpha-positive, or FRa, platinum chemotherapy-resistant ovarian cancer who received at least one but no more than three prior treatments and for whom chemotherapy is appropriate as the next line of therapy.

ImmunoGen is evaluating mirvetuximab soravtansine in a phase 3 trial, named Forward I, to treat patients with this particular type of ovarian cancer and expects to report results in the first half of 2019.

The company is also evaluating the drug in combination with Roche Holding AG's Avastin or Merck & Co. Inc.'s Keytruda in patients with FRa-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

The FDA's fast track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.