FDA Grants Breakthrough Therapy Designation to MPDL3280A for Non–Small Cell Lung Cancer


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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. ■



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