U.S. FDA approves AstraZeneca’s Tagrisso-chemo combo – ET HealthWorld | Pharma

New Delhi: A combination of AstraZeneca‘s blockbuster cancer drug Tagrisso with chemotherapy to treat a type of lung cancer has been approved by the US 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 per cent 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 percent in 2023, it is currently approved as monotherapy in more than 100 countries including in the US, European UnionChina and Japan.

  • Published On Feb 17, 2024 at 02:28 PM IST

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