Roche

The US Food and Drug Administration (FDA) has granted second breakthrough therapy designation for Swiss drug-maker Roche’s investigational cancer immunotherapy, MPDL3280A.

The company has received approval for MPDL3280A to treat people with Programmed Death-Ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy.

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Also known as anti-PDL1 and RG7446, MPDL3280A is an investigational monoclonal antibody, designed to target PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells.

Roche global product development head and chief medical officer 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.

"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."

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The approval was based on early results of MPDL3280A in people whose NSCLC was characterised as PD-L1-positive by an investigational test being developed by the company.

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Roche noted that all studies of MPDL3280A are prospectively evaluating PD-L1 expression.

The current pivotal trials of MPDL3280A include lung and bladder cancer, and the company plans to commence Phase III studies in additional tumour types this year.

The MPDL3280A received FDA breakthrough therapy designation in metastatic bladder cancer in 2014.

Image: Poorly differentiated non-small cell carcinoma NOS with a massive host inflammatory response. Photo: courtesy of Yale Rosen.