(Alliance News) - AstraZeneca PLC said Thursday it has received marketing authorization from China's National Medical Products Administration for its stage III non-small cell lung cancer drug Imfinzi.
The drugmaker said the approval of Imfinzi is based on results from the primary analysis of progression-free survival and supported by overall survival from the phase III PACIFIC trial.
Imfinzi reduced the risk of death by 32% and prolonged the time patients lived without disease progression or death by more than 11 months, the company said.
"This approval illustrates our long-standing commitment to improving health outcomes in China, where more than one-third of the world's lung cancer diagnoses and deaths occur," said Dave Fredrickson, executive vice president of Astra's Oncology Business Unit. "As the global standard of care in this curative-intent setting, Imfinzi is an important new option for patients in China."
Astra said Imfinzi is also approved for previously treated patients with advanced bladder cancer in 11 countries, including the US.
At the beginning of December, AstraZeneca together with partner Merck & Co Inc also received marketing authorization from China's National Medical Products Administration for their Lynparza drug.
AstraZeneca shares were down 0.2% in London at 7,289.00 pence each on Thursday morning.
By Loreta Juodagalvyte; loretajuodagalvyte@alliancenews.com
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