Roche's MPDL3280A granted FDA Breakthrough Therapy Designation in non-small cell lung cancer

The US Food and Drug Administration has granted Breakthrough Therapy Designation for MPDL3280A (anti-PDL1) in non-small cell lung cancer, developed by Swiss drug major Roche (ROG: SIX).

This is the second Breakthrough Therapy Designation granted to MPDL3280A, following the designation for bladder cancer in 2014. The new designation was granted to treat patients with PD-L1-positive (Programmed Death-Ligand 1) non-small cell lung cancer, whose disease has progressed during or after platinum-based chemotherapy.

Sandra Horning, Roche’s chief medical officer and head of global product development, said: “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. We are committed to personalized health care, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines.”