FILE PHOTO: AstraZeneca's cancer medicine Imfinzi is seen in this undated handout image provided to Reuters, June 30, 2022.  AstraZeneca/Handout via REUTERS/File Photo
United States

FDA Grants Priority Review to AstraZeneca’s Imfinzi

AstraZeneca said the U.S. FDA has granted its blockbuster cancer drug Imfinzi a priority review for patients with limited-stage small cell lung cancer in the United States.

(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'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.

(Reporting by Yadarisa Shabong in Bengaluru; Editing by Janane Venkatraman)

Pope Leo names French archbishop to lead Vatican abuse commission

Lula hints at 2026 run, eyes historic fourth presidential term

BRICS leaders meet in Rio, push to reform Western institutions

Trump signs sweeping tax, spending cuts at Fourth of July event

Deadly Texas floods sweep away campers, children still missing