Also known as anti-PDL1 and RG7446, MPDL3280A is an investigational monoclonal antibody, designed to interfere with a protein called PD-L1.
The approval was granted to treat these patients whose disease has progressed during or after platinum-based chemotherapy.
Roche chief medical officer and head of Global Product Development Dr Sandra Horning 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 personalised healthcare, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines."
The breakthrough status was granted based on early results of MPDL3280A in people whose NSCLC was characterized as PD-L1-positive by an investigational test being developed by the Swiss firm.
In 2014, the US FDA granted the first breakthrough therapy designation for MPDL3280A in metastatic bladder cancer.