(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.
Shares hit a record high of 130.48 pounds, taking its market capitalisation to about 202 billion pounds ($259 billion) and cementing its place as London’s most valuable listed company.
The Anglo-Swedish drugmaker late on Wednesday also convinced a federal judge in Delaware to throw out a jury’s decision that the company owes $107.5 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 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.
AstraZeneca’s shares hit all-time highs for the fourth-straight session on Thursday.
Over the course of the week, its other cancer drugs received approvals in the European Union and China. London’s FTSE 100 index has also been on positive territory so far this week.
U.S. hedge fund Soros late on Wednesday also disclosed in a filing that it had significantly raised its stake in the London-listed company.
($1 = 0.7788 pounds)
(Reporting by Yadarisa Shabong in Bengaluru; Editing by Janane Venkatraman and David Evans)
