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AstraZeneca PLC on Thursday, along with pharmaceutical peer Merck & Co Inc, said that Lynparza has been approved in China for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.
Cambridge, England-based AstraZeneca said these adult patients are in complete partial response to first-line platinum-based chemotherapy in combination with bevacizumab, and whose cancer is associated with homologous recombination deficiency-positive status.
AstraZeneca said the approval by China's National Medical Products Administration was based on a Paola-1 phase III trial which showed Lynparza, whose generic name is olaparib, plus bevacizumab demonstrated a substantial progression-free survival improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer.
Bevacizumab is a cancer treatment drug, and Lynparza is a first-in-class poly-ADP ribose polymerase inhibitor and the first targeted treatment to block DNA damage response in cells or tumours harbouring a deficiency in homologous recombination repair.
Dave Fredrickson, executive vice president of AstraZeneca's Oncology Business Unit, said: ‘The maintenance treatment of Lynparza in combination with bevacizumab has shown to both improve progression-free survival and provide a clinically meaningful improvement in overall survival in patients with HRD-positive advanced ovarian cancer following response to platinum-based chemotherapy.’
Lynparza, which is being jointly developed and commercialised by AstraZeneca and Merck, has been used to treat over 75,000 patients worldwide.
In China, ovarian cancer is the third most common gynaecologic cancer, and the eighth most common cancer in women worldwide.
The approval came after AstraZeneca said on Wednesday that its Tezpire severe asthma treatment was approved for use in the EU by the European Commission.
Shares were down 0.4% at 10,054.00 pence each on Thursday morning in London.
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