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FDA grants breakthrough therapy designation to MPDL3280A for PDL1–positive NSCLC
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The FDA granted breakthrough therapy designation to MPDL3280A for the treatment of patients with PD-L1–positive non–small cell lung cancer who experienced disease progression during or after platinum-based chemotherapy, according to a press release from the drug’s manufacturer.
MPDL3280A (Genentech) is an investigational immunotherapy designed to target the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells to prevent it from binding to PD-1 and B7.1 on the surface of T cells. MPDL3280A may enable the activation of T cells by inhibiting PD-L1.
The FDA based its decision on early results of MPDL3280A in patients with PD-L1–positive NSCLC.
“Lung cancer is the leading cause of cancer death globally, and we are pleased the FDA has granted breakthrough designation for MPDL3280A in non–small cell lung cancer,” Sandra Horning, MD, chief medical officer and head of global product development of Genentech, said in a press release. “We are committed to personalized healthcare, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines.”
The FDA previously granted breakthrough designation to MPDL3280A for the treatment of metastatic bladder cancer.
Genentech is conducting studies of MPDL3280A in bladder and lung cancers and plans to initiate phase 3 studies in additional tumor types this year.