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AstraZeneca’s Imfinzi drug gets FDA priority review for type of lung cancer
2024-08-15 00:00:00.0     海峡时报-世界     原网页

       LONDON – AstraZeneca said on Aug 15 the US Food and Drug Administration (FDA) has granted its blockbuster cancer drug Imfinzi a priority review for patients with limited-stage small cell lung cancer in the United States.

       The Anglo-Swedish drugmaker late on Aug 14 also convinced a federal judge in Delaware to throw out a jury’s decision that the company owes US$107.5 million (S$142 million) for infringing cancer-drug patents belonging to Pfizer subsidiary Wyeth.

       The date for the FDA’s regulatory decision is anticipated during the fourth quarter of 2024, it said.

       AstraZeneca’s application was based on positive late-stage data that showed that the drug improved overall survival and progression-free survival in patients with a type of lung cancer, whose disease has not progressed following platinum-based concurrent chemoradiotherapy.

       AstraZeneca said Imfinzi was also recently granted Breakthrough Therapy Designation by the FDA in the same setting, which will help accelerate the regulatory review.

       Small cell lung cancer is a highly aggressive form of lung cancer.

       Imfinzi is a human monoclonal antibody, which works by blocking a tumour’s ability to evade and dampen the immune system, while also boosting the body’s anti-cancer immune response, offering an alternative to chemotherapy.

       Over the course of the week, AstraZeneca’s other cancer drugs received approvals in the European Union and China. REUTERS


标签:综合
关键词: lung cancer     Imfinzi     survival     patients     Drug Administration     AstraZeneca     granted