Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to MPDL3280A (anti-PDL1 and RG7446) for the treatment of patients with Programmed Death-Ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy. MPDL3280A is an investigational monoclonal antibody designed to interfere with PD-L1.
The Breakthrough Therapy designation was based on results of MPDL3280A in patients whose NSCLC was PD-L1 positive. All studies of MPDL3280A are prospectively evaluating PD-L1 expression. Some studies will evaluate the MPDL3280A regardless of a tumor’s PD-L1 status; other studies are evaluating the MPDL3280A only in people whose tumors are characterized as PD-L1 positive.
Previously in 2014, the FDA granted MPDL3280A Breakthrough Therapy designation for patients with metastatic bladder cancer. Genentech plans to initiate Phase 3 studies in additional tumor types later this year.
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