Lung cancer is the leading cause of cancer death globally. Non-small cell lung cancer (NSCLC) is the most prevalent type of the disease.
Roche, the world’s largest biotech company and a leader in research-focused healthcare, has announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for its investigational cancer immunotherapy MPDL3280A (anti-PDL1). This is the second FDA Breakthrough Therapy Designation for MPDL3280A following bladder cancer in 2014.
The designation was granted for the treatment of patients with PD-L1-positive (Programmed Death-Ligand 1) non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy and also a suitable targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor.MPDL3280A is a monoclonal antibody designed to target a protein called PDL1 in on tumor cells and tumor-infiltrating immune cells. By preventing PD-L1, MPDL3280A could activate T cells, restoring their ability to effectively detect and attack tumor cells.
The designation is based on early results of MPDL3280A in people whose NSCLC was characterized as PD-L1-positive by an investigational test being developed by Roche. While the aim of all studies of MPDL3280A is to evaluate PD-L1 expression, some studies will analyze the effects of the medicine regardless of a tumor’s PD-L1 status and others will evaluate it only in people whose tumors have been termed PD-L1 positive.
Sandra Horning, M.D., chief medical officer and head of Global Product Development at Roche said, “We are committed to personalized healthcare, developing medicines like MPDL3280A with companion tests that may helchemotherapy and also p us identify those who may be appropriate candidates for our medicines.”
MPDL3280A received its first breakthrough therapy designation from the FDA last year for the treatment of metastatic bladder cancer and the recent designation has further added to the potential success of the cancer immunotherapy.
Roche plans ongoing pivotal trials examining MPDL3280A in lung and bladder cancer, and phase III studies in other cancer types scheduled to be launched this year.
Along with developing medicines to redefine treatment in oncology, Roche’s chemistry analyzers and innovative diagnostic tests play a key role in the groundbreaking area of integrated healthcare solutions.