Genentech's Anti-PD-L1 Agent Receives Breakthrough Status in Advanced NSCLC

With 3 I-O agents have already been approved for metastatic melanoma, 2 from BMS and 1 from Merck, the race for NSCLC has tightened with multiple ongoing clinical trials.

Genentech, a member of the Roche Group, announced today that it has received a second Breakthrough Therapy Designation from FDA for its investigational cancer immunotherapy MPDL3280A (anti-PDL1). The designation was granted for the treatment of people with PD-L1 (Programmed Death-Ligand 1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy (and an appropriate targeted therapy for those with an 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," said Sandra Horning, MD, chief medical officer and head of Global Product Development. "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."

Read the complete press release: