Roche: FDA grants priority review to lung cancer drug
(CercleFinance.com) - Roche said on Wednesday that US regulators have granted priority review to its Tecentriq immunotherapy as first-line treatment of certain people with advanced non-small cell lung cancer.
The Food and Drug Administration has accepted the company's supplemental biologics license application and granted priority review for the drug as initial treatment for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression.
The FDA is expected to make a decision on approval by 19 June.
Tecentriq is designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, enabling the activation of T-cells.
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