The U.S. Food and Drug Administration (FDA) granted Genentech, a member of the Roche Group, a Breakthrough Therapy Designation for its cancer immunotherapy trial MPDL3280A (anti-PDL1).
The company’s second Breakthrough Therapy Designation was given for the treatment of patients with Programmed Death-Ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC), whose cancer grew after or during platinum-based chemotherapy. The designation was founded upon initial findings of Genentech’s investigational cancer immunotherapy trial in NSCLC patients with PD-L1.
"Lung cancer is the leading cause of cancer death globally, and we are pleased the FDA has granted breakthrough designation for MPDL3280A in non-small cell lung cancer," Chief Medical Officer and Head of Global Product Development Dr. Sandra Horning said. "We are committed to personalized health care, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines."
In 2014, the FDA granted the first Breakthrough Therapy Designation for MPDL3280A, used to treat metastatic bladder cancer. In addition to current MPDL3280A studies in bladder and lung cancer, Genentech plans to launch further studies in 2015.
Breakthrough Therapy Designations were created to advance the creation and assessment of medications for serious diseases and to provide patients with prompt access to investigational treatments.