Roche’s Investigational Cancer Immunotherapy Gains FDA’s Breakthrough Therapy DesignationBy
FDA has granted Breakthrough Therapy Designation in bladder cancer for Roche’s investigational cancer immunotherapy MPDL3280A.
MPDL3280As 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.
The Food and Drug Administration Safety and Innovation Act, passed in July 2012, gave the FDA the ability to designate a drug a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. A breakthrough therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program. Last year (2013) was the first year any new drug was approved with the breakthrough designation.
To date, four drugs with breakthrough therapy designation have been approved by FDA: Gilead Sciences’ Sovaldi (sofosbuvir) to treat chronic hepatitis C virus infection, Janssen Biotech/Pharmacyclics’ Imbruvia (ibrutinib) to treat mantle cell lymphoma, and Genentech/Roche's Gazyva (obinutuzumab) to treat chronic lymphocyte leukemia, and Novartis’ Zykadia (ceritinib), designed to treat a certain type of metastatic non-small cell lung cancer .