Roche Group member, Genentech has received US Food and Drug Administration (FDA) official approval of priority review designation for trastuzumab emtansine Biologics License Application (BLA).
Trastuzumab Emtansine is designed to treat people with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin and a taxane chemotherapy.
European Medicines Agency has also accepted to review Roche's Marketing?Authorization Application for trastuzumab emtansine for people with HER2-positive metastatic breast cancer.
ImmunoGen's TAP technology uses monoclonal antibodies to deliver one of its proprietary cancer-killing agents specifically to tumor cells.
Roche develops trastuzumab emtansine globally under an agreement between ImmunoGen and Genentech.
ImmunoGen's TAP technology uses monoclonal antibodies to deliver one of its proprietary cancer-killing agents specifically to tumor cells.
ImmunoGen president and CEO Daniel Junius said, "This decision underscores the urgent need to have new and more effective treatment options available for patients with this cancer."
The FDA approves Priority Review designation to drugs, which may offer advances in treatment or provide a treatment where no adequate therapy exists.