FDA Grants Breakthrough Therapy Designation for MPDL3280A, an anti-PDL1 Investigational Cancer Immunotherapy for Non-Small Cell Lung Cancer

CancerConnect News: The investigational cancer immunotherapy MPDL3280A (anti-PDL1) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). The designation was granted for the treatment of people with PD-L1 (Programmed Death-Ligand 1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy.

Lung cancer remains the leading cause of cancer-related deaths worldwide. In the United States, NSCLC accounts for 75–80% of all lung cancers. Although progress has been made in recent years, the majority of patients with advanced stage lung cancer still die from their disease. New treatments are sorely needed.  MPDL3280A has recently received breakthrough therapy status from the U.S. Food and Drug Administration.

MPDL3280A is an investigational monoclonal antibody designed to interfere with a protein called 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.

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. The FDA previously granted Breakthrough Therapy Designation for MPDL3280A in metastatic bladder cancer in 2014.

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