FDA Grants Breakthrough Therapy Designation for Lung Cancer Drug

Treatment was previously designated as a breakthrough therapy for bladder cancer.

The FDA on Sunday granted a second breakthrough therapy designation for an investigational cancer drug manufactured by Genentech.

The experimental immunotherapy MPDL3280A (anti-PDL1) was granted the designation to treat PD-L1 (Programmed Death-Ligand 1) positive non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-based chemotherapy. The drug is also an appropriate targeted therapy for EGFR mutation-positive or ALK-positive tumor.

"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 Genentech Global Product Development 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 breakthrough designation followed an investigational test developed by Roche of MPDL3280A in patients with NSCLC characterized as PD-L1 positive. Some future studies of MPDL3280A are planned to examine the drug regardless of a tumor’s PD-L1 status, while other studies will evaluate the treatment just in patients with tumors characterized as PD-L1 positive.

MPDL3280A acts as a monoclonal antibody that interferes with the PD-L1 protein. The drug targets PD-L1 expressed on tumor cells and on tumor-infiltrating immune cells.

The therapy prevents PD-L1 from attaching to PD-1 and B7.1 on the surface of T-cells. Through this process, MPDL3280A may enable T-cell activation, which restores their ability to effectively find and attack tumor cells.

The drug was previously granted breakthrough therapy designation for the treatment of bladder cancer in 2014.