AstraZeneca: FDA grants priority review for Imfinzi
(CercleFinance.com) - AstraZeneca announced on Thursday that the US FDA has granted priority review to its Biologics License Application for its Imfinzi immunotherapy in the treatment of non-small cell cancer.
The FDA is expected to render its decision in Q4 2024, the pharmaceutical company said.
The company explained that the FDA's opinion concerns the treatment of patients with localized non-small-cell cancer whose disease has not progressed following chemotherapy.
AstraZeneca says it has also been granted 'breakthrough' status by the Food and Drug Administration (FDA) in this indication, a designation that aims to accelerate the development and review of drugs to treat serious diseases.
In Phase III clinical trials, Imfinzi reduced the risk of death by 27% compared with placebo, with life expectancy reaching 55.9 months versus 33.4 months in the placebo group.
On the London Stock Exchange, AstraZeneca shares were up 0.7% on Thursday morning following these announcements, outperforming a timid 0.1% gain in the FTSE 100 index.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The FDA is expected to render its decision in Q4 2024, the pharmaceutical company said.
The company explained that the FDA's opinion concerns the treatment of patients with localized non-small-cell cancer whose disease has not progressed following chemotherapy.
AstraZeneca says it has also been granted 'breakthrough' status by the Food and Drug Administration (FDA) in this indication, a designation that aims to accelerate the development and review of drugs to treat serious diseases.
In Phase III clinical trials, Imfinzi reduced the risk of death by 27% compared with placebo, with life expectancy reaching 55.9 months versus 33.4 months in the placebo group.
On the London Stock Exchange, AstraZeneca shares were up 0.7% on Thursday morning following these announcements, outperforming a timid 0.1% gain in the FTSE 100 index.
Copyright (c) 2024 CercleFinance.com. All rights reserved.