FDA Grants Breakthrough Therapy Designation to MPDL3280A for Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Genentech’s investigational cancer immunotherapy MPDL3280A for the treatment of PD-L1–positive non–small cell lung cancer (NSCLC) that has progressed during or after platinum-based chemotherapy (and an appropriate targeted therapy for those with an EGFR mutation–positive or ALK-positive tumor).
MPDL3280A (also known as anti–PD-L1) is an investigational monoclonal antibody designed to interfere with a protein called programmed death ligand 1 (PD-L1). MPDL3280A 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. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells.
This Breakthrough Therapy designation is based on early results of MPDL3280A in patients whose NSCLC was characterized as PD-L1–positive by an investigational test being developed by Roche. All studies of MPDL3280A are prospectively evaluating PD-L1 expression. Some studies will evaluate the medicine regardless of a tumor’s PD-L1 status; other studies are evaluating the medicine only in people whose tumors are characterized as PD-L1–positive.
MPDL3280A previously received Breakthrough Therapy designation for metastatic bladder cancer in 2014.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
