AstraZeneca’s Imfinzi gets FDA priority review for type of lung cancer
2024.08.15 02:47
(Reuters) -AstraZeneca said on Thursday the U.S. 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 date for the FDA’s regulatory decision is anticipated during the fourth quarter of 2024, the Anglo-Swedish drugmaker said.
AstraZeneca (NASDAQ:)’s application was based on positive late-stage data that showed 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.
