AstraZeneca's Tagrisso plus chemo approved by China for first-line cancer therapy

AstraZeneca says approval by China's NMPA based on trials on patients given combination treatment

 China has approved the use of AstraZeneca's (AZN.L), opens new tab blockbuster cancer drug Tagrisso in combination with chemotherapy as a first line of treatment for adults with a type of advanced lung cancer, the company said on Wednesday.

AstraZeneca said the approval by China's National Medical Products Administration (NMPA) was based on trials which showed that patients given the combination treatment lived without the disease getting worse longer than those given just Tagrisso.

The median progression-free survival of patients treated with Tagrisso and chemotherapy was 25.5 months, 8.8 months more than those treated with just Tagrisso.

The decision by China's National Medical Products Administration was supported by findings from a phase 3 trial demonstrating that Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone, as assessed by investigators.

This approval is significant for the treatment of EGFR-mutated lung cancer, particularly in China, where it provides another effective treatment option alongside Tagrisso monotherapy.