15th Aug 2024 08:56
(Alliance News) - AstraZeneca PLC on Thursday said Imfinzi has been granted priority review and breakthrough therapy designation for patients with limited-stage small cell lung cancer in the US.
The Cambridge-based pharmaceuticals company's supplemental Biologics License Application for Imfinzi was based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.
This has been accepted and granted priority review in the US by the Food & Drug Administration.
The FDA grants priority review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024.
Imfinzi was also recently granted breakthrough therapy designation by the FDA. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.
AstraZeneca Executive Vice President, Oncology R&D Susan Galbraith said: "This priority review reinforces the potential of Imfinzi to transform outcomes for patients as the first and only immunotherapy to demonstrate a survival benefit in limited-stage small cell lung cancer."
In the ADRIATIC trial, Imfinzi reduced the risk of death by 27% versus placebo based on an overall survival hazard ratio of 0.73.
An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% on placebo.
Imfinzi also reduced the risk of disease progression or death by 24% based on a progression-free survival hazard ratio of 0.76.
An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% on placebo.
The safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine. No new safety signals were observed.
Shares in AstraZeneca rose 0.8% to 13,002.16 pence in London on Thursday. The wider FTSE 100 was up 0.1% at 8,270.97.
By Jeremy Cutler, Alliance News reporter
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