The US Food and Drug Administration (FDA) has granted priority review to Switzerland-based Roche for its Tecentriq (atezolizumab) in combination with chemotherapy as the first-line treatment of a form of triple-negative breast cancer, it was reported yesterday.
The US FDA designation for the product chemo combination is for triple-negative breast cancer patients whose condition is unresectable locally advanced or metastatic and whose disease expresses the PD-L1 protein, as identified by PD-L1 biomarker testing. The chemotherapy intended to be utilised in combination with the Roche drug is Abraxane [albumin-bound paclitaxel; nab-paclitaxel]).
The product is a monoclonal antibody that inhibits the PD-L1 protein expressed on tumour cells and tumour-infiltrating immune cells. The FDA is expected to make a decision regarding approval of the combination therapy for the type of breast cancer by 12 March 2019.
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