ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced that Genentech, a member of the Roche Group, has disclosed that the U.S. Food and Drug Administration (FDA) has officially accepted the Biologics License Application (BLA) for trastuzumab emtansine and granted it Priority Review. The proposed indication is for the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. It also disclosed that Roche's Marketing Authorization Application for trastuzumab emtansine for people with HER2-positive metastatic breast cancer has been accepted for review by the European Medicines Agency.
"We're very pleased that the FDA has granted Priority Review to the trastuzumab emtansine BLA," commented Daniel Junius, President and CEO. "This decision underscores the urgent need to have new and more effective treatment options available for patients with this cancer."