Roche's Genentech unit announced Monday that the FDA granted breakthrough therapy status to its anti-PDL1 therapy MPDL3280A in certain patients with non-small-cell lung cancer (NSCLC). Last year, the agency awarded the experimental monoclonal antibody breakthrough therapy status for metastatic bladder cancer.
The company noted that the new designation was granted for the treatment of people with PD-L1-positive NSCLC whose disease has progressed during or after platinum-based chemotherapy. Genentech said the decision was based on early results in people whose NSCLC was characterised as PD-L1 positive by an experimental test being developed by Roche.
Sandra Horning, the company's chief medical officer, commented "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."
According to Genentech, studies of MPDL3280A in NSCLC are prospectively evaluating PD-L1 expression, with some trials assessing the drug regardless of a tumour's PD-L1 status, while others are only evaluating the medicine in people whose tumours are characterised as PD-L1 positive. Pivotal studies of MPDL3280A are ongoing in NSCLC and bladder cancer, with the drugmaker indicating that it plans to initiate further Phase III studies in additional tumour types this year.
For related analysis, see ViewPoints: Roche turns up the heat in NCSLC immuno-oncology race.
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