4th May 2022 09:19
(Alliance News) - AstraZeneca PLC on Wednesday said its checkpoint inhibitor drug Imfinzi, generically durvalumab, has been granted priority review by the US Food & Drug Administration.
The Cambridge, England-based pharmaceutical company said the application covers the use of Imfinzi as a combination treatment with chemotherapy for the treatment of patients with locally advanced or metastatic biliary tract cancer.
The FDA will make a decision during the third quarter of 2022, AZ said.
The priority review designation was based on interim results from the Topaz-1 phase III trial, which showed Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone, and showed a statistically significant reduction in disease progression.
Imfinzi is a human monoclonal antibody. It is approved in several countries for select applications in the treatment of non-small cell lung cancer, extensive-stage small cell lung cancer and bladder cancer. In December 2020, it was granted orphan drug designation in the US for the treatment of BTC.
"We are working closely with the FDA to bring the first immunotherapy-based option to patients with this devastating cancer and potentially set a new standard of care with Imfinzi plus chemotherapy," said Executive Vice President of Oncology Research & Development Susan Galbraith.
Imfinzi is being tested as a single and combination for the treatment of several other cancers, including lung cancers, bladder cancer, GI cancers, ovarian cancer and endometrial cancer.
Shares in AstraZeneca were 0.6% lower at 10,618.00 pence each in London on Wednesday morning.
By Elizabeth Winter; [email protected]
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