AstraZeneca receives Chinese marketing approval for Tagrisso
Biopharmaceutical giant AstraZeneca has received marketing authorisation for its lung cancer treatment Tagrisso from China's National Medical Products Administration.
AstraZeneca
12,026.00p
17:14 25/04/24
FTSE 100
8,078.86
17:14 25/04/24
FTSE 350
4,434.34
17:09 25/04/24
FTSE All-Share
4,387.94
16:49 25/04/24
Pharmaceuticals & Biotechnology
22,750.48
17:09 25/04/24
AstraZeneca was granted authorisation to market the drug as a first-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer whose tumours had genetic mutations of epidermal growth factor receptors, exon 19 deletions or exon 21 substitutions.
The approval follows AstraZeneca's priority review pathway and was based on results from its phase III FLAURA trial, which provided a "statistically-significant and clinically-meaningful improvement in progression-free survival".
AstraZeneca's vice president of oncology, Dave Fredrickson, said: "The FLAURA trial has demonstrated the potential of Tagrisso as a new standard of care and as an important new first-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 was approved in China in March 2017 and added to the National Reimbursement Drug List for the second-line treatment of adult patients in January.
At 1045 BST, the shares were up 0.1% at 7,435p.