AstraZeneca's Tagrisso-chemo combo given priority review in US

[October 16, 2023]  (Reuters) -A combination of AstraZeneca's blockbuster cancer drug Tagrisso, with chemotherapy to treat a type of lung cancer, has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA), the British drugmaker said on Monday.

It would be used to treat adults with a type of advanced lung cancer, AstraZeneca said, adding that the decision from the regulator was based on a late-stage trial 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 FDA grants priority review to applications for medicines that, if approved, would offer significant improvements over available options.

Tagrisso, which clocked $2.92 billion in sales in the first half of 2023, is currently approved as monotherapy in more than 100 countries including in the U.S., European Union, China and Japan.

Test tubes are seen in front of a displayed AstraZeneca logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/Illustration

(Reporting by Eva Mathews in Bengaluru; Editing by Mrigank Dhaniwala and Rashmi Aich)

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.