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FDA's Breakthrough Designation to Anti-PDL1 Immunotherapy for NSCLC

doi: 10.1097/01.COT.0000461883.50685.12
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The U.S. Food and Drug Administration has granted breakthrough therapy designation to the investigational cancer immunotherapy MPDL3280A for the treatment of patients with PD-L1 positive non-small cell lung cancer whose disease has progressed during or after platinum-based chemotherapy. MPDL3280A, made by Genentech, 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, which may enable the activation of T cells and restore their ability to effectively detect and attack tumor cells.

The breakthrough therapy designation, enacted as part of the FDA's 2012 Safety and Innovation Act, was created to expedite the development and review time of a potential new drug for serious or life-threatening disease where early clinical evidence suggests the drug may demonstrate substantial improvement compared with existing therapies.

Approximately 224,210 Americans were diagnosed with lung cancer in 2014, 84 percent of which were NSCLC, according to estimates from the American Cancer Society.

The FDA granted breakthrough therapy designation to MPDL3280A for the treatment of bladder cancer last year (OT 6/25/14 issue). The drug is currently being evaluated in Phase III trials in both lung and bladder cancers.

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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