U.S. FDA approves AstraZeneca’s Tagrisso-chemo combo

By Thomson Reuters Feb 16, 2024 | 9:44 PM

(Reuters) – A combination of AstraZeneca’s blockbuster cancer drug Tagrisso with chemotherapy to treat a type of lung cancer has been approved by the U.S. Food and Drug Administration (FDA), the company said in a statement on Friday.

The drug would be used to treat adults with a type of advanced lung cancer, AstraZeneca said, adding that the FDA’s approval was based on trials which extended median progression-free survival (PFS) by nearly nine months.

The term PFS refers to how long a patient lives without the disease getting worse after treatment.

The Phase 3 trials, called FLAURA2, showed that when adding chemotherapy to Tagrisso, the risk of disease progression or death was reduced by 38% when compared to Tagrisso alone.

The approval from the regulator comes after it had granted the drug priority review in October.

Lung cancer drug Tagrisso’s sales grew 9% in 2023, it is currently approved as monotherapy in more than 100 countries including in the U.S., European Union, China and Japan.

(Reporting by Gursimran Kaur in Bengaluru)