AZ’s Tagrisso secures China approval in first-line advanced lung cancer

pharmafile | September 4, 2019 | News story | Research and Development, Sales and Marketing AstraZeneca, China, Tagrisso, lung cancer, pharma 

AstraZeneca’s Tagrisso (osimertinib) has secured approval in China from the country’s National Medical Products Administration (NMPA) in the first-line treatment of locally-advanced or metastatic non-small cell lung cancer (NSCLC), it has emerged.

The authorisation, achieved via the Priority Review Pathway, covers adult patients whose tumours have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions.

The decision was based on data which showed that Tagrisso improved progression-free survival by a median of 18.9 months compared to 10.2 months with a standard EGFR tyrosine kinase inhibitor, an improvement observed consistently across all patient subgroups, including those with central nervous system metastases.

Dave Fredrickson, AZ’s Executive Vice President, Oncology, said: “The FLAURA trial has demonstrated the potential of Tagrisso as a new standard of care and as an important new 1st-line treatment option for non-small cell lung cancer patients in China, where approximately 30-40% are diagnosed with an EGFR mutation – more than any other country in the world.”

Matt Fellows

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