4th Sep 2019 08:07
(Alliance News) - Pharmaceutical major AstraZeneca PLC on Wednesday said Tagrisso has been approved in China as a first-line treatment in advanced non-small cell lung cancer.
Non-small cell lung cancer is the most common type of lung cancer, representing around 80% to 85% of lung cancer cases.
Tagrisso's approval is for adults whose lung cancer is locally advanced or metastic - meaning it has spread to another part of the body - and whose tumours have certain kinds of genetic mutations in their epidermal growth factor receptor.
Approval from China's National Medical Products Administration for Tagrisso in this setting was based on the results of the phase 3 Flaura trial, which showed that "first-line use of Tagrisso provided a statistically-significant and clinically-meaningful improvement in progression-free survival".
In the Flaura trial, Tagrisso increased the time patients lived without death or disease progression by a median of 18.9 months, compared to 10.2 months with a standard EGFR tyrosine kinase inhibitor.
Dave Fredrickson, executive vice president of Oncology at Astra, 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."
Tagrisso has already been approved in China in 2017 as a second-line treatment for non-small cell lung cancer.
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