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(Alliance News) - AstraZeneca PLC said Thursday that its Lynparza drug has been approved in China for the treatment of a form of castration-resistant prostate cancer.
China's National Medical Products Administration granted approval to treat adult patients with germline or somatic BRCA-mutated metastatic prostate cancer who have progressed following treatment that included a new hormonal agent.
The approval was based on an earlier trial which found the use of Lynparza led to a "substantial improvement" in radiographic progression-free survival and overall survival compared to other treatments currently used. The trial showed Lynparza reduced the risk of disease progression or death by 78%.
"This approval begins a new era of precision medicine for patients in China with advanced prostate cancer who have historically had a poor prognosis and few treatment options," said Dave Fredrickson, Executive Vice President of Oncology.
"Lynparza more than tripled radiographic progression-free survival in the PROfound trial and is the only PARP inhibitor to show an overall survival benefit compared to treatment with new hormonal agents for men with BRCA-mutated metastatic castration-resistant prostate cancer."
Lynparza has been co-developed by AstraZeneca and New Jersey, US-based pharmaceutical drugs firm Merck & Co Inc.
Shares in AstraZeneca were up 0.2% in London on Thursday morning at 8,335.00 pence each.
By Will Paige; willpaige@alliancenews.com
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