AstraZeneca: Imfinzi to be reviewed faster by FDA
(CercleFinance.com) - AstraZeneca said that an application to gain approval for a new usage of its human monoclonal antibody Imfinzi won a priority review status from US health regulators, which means that the drug will be reviewed faster than usual.
The drugmaker today announced that the Food and Drug Administration (FDA) has granted priority review for Imfinzi for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC).
SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly despite initial response to chemotherapy.
Imfinzi is already approved for the treatment of stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in 54 countries, including the US, Japan and the EU.
Copyright (c) 2019 CercleFinance.com. All rights reserved.