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(Alliance News) - AstraZeneca PLC on Monday reported its Imfinzi drug has been approved in China for the treatment of extensive-stage small cell lung cancer.
The approval by China's National Medical Products Administration was based on positive results from its Caspian phase three trial, which showed that Imfinzi and chemotherapy demonstrated a "statistically significant and clinically meaningful improvement in overall survival" versus chemotherapy treatment alone.
"Today's approval of Imfinzi plus chemotherapy brings an important global standard of care to patients with extensive-stage small cell lung cancer in China, who have had few treatment options and a dire prognosis," Dave Fredrickson, Executive Vice President of Oncology Business commented.
"Physicians can now offer these patients a well-tolerated immunotherapy regimen with sustained overall survival and prolonged treatment response, as well as convenient dosing."
The drugmaker said that this is the first time physicians have had the choice to combine immunotherapy with cisplatin, a preferred chemotherapy in China.
Small cell lung cancer is a highly aggressive, fast-growing form of lung cancer with a five-year survival rate of just 7%.
Imfinzi can be used when small cell lung cancer has not spread outside the chest, cannot be removed by surgery, and has responded or stabilised with chemotherapy, given at the same time as radiation therapy.
Shares in AstraZeneca were trading down 1.2% at 8,244.00 pence each in London early on Monday morning.
By Will Paige; willpaige@alliancenews.com
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