US-based Genentech recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational cancer immunotherapy.
The agency granted the designation to Genentech’s MPDL3280A for treatment of patients with Programmed Death-Ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy. Genentech’s MPDL3280A has already received Breakthrough Therapy Designation for treatment of patients with metastatic bladder cancer. The designation is designed to speed up the development and review of drugs intended to treat serious diseases and help ensure patients have access to them through FDA approval as soon as possible.
MPDL3280A is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. The drug is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. The inhibition of PD-L1 may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells.
The agency granted the drug Breakthrough Therapy Designation following early results of MPDL3280A in people whose NSCLC was characterized as PD-L1 positive by an investigational test being developed by Roche. All studies evaluating the antibody are prospectively evaluating PD-L1 expression.
“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,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “We are committed to personalized healthcare, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines.”
It is estimated that more than 221,000 Americans will be diagnosed with lung cancer in 2015, according to the American Cancer Society (ACS). Among all lung cancers, NSCLC accounts for 85 percent. It is estimated that approximately 60 percent of lung cancer diagnoses in the US are made when the disease is in the advanced stages.
MPDL3280A is in ongoing pivotal studies in lung and bladder cancer, and Genentech said that it plans to start Phase III studies in other tumor types later this year.