(Alliance News) - AstraZeneca PLC on Wednesday celebrated the approval of Tagrisso plus chemotherapy for a cancer form in China, a day after a similar approval in Japan.
The Cambridge-based pharmaceutical company said China's National Medical Products Administration approved its cancer drug Tagrisso plus chemotherapy as first-line treatment for some adult sufferers of non-small cell lung cancer.
The approval is based on results from a phase 3 trial, which showed that Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy.
The announcement of the approval came a day after AstraZeneca announced a similar backing in Japan.
Ying Cheng, director of Jilin Lung Cancer Diagnosis & Treatment Centre, and principal investigator in China, said: "The approval of osimertinib with the addition of chemotherapy in China is critical for the treatment of the largest population of patients with EGFR-mutated lung cancer worldwide. These patients will now have a choice of two highly effective osimertinib-based options for 1st-line treatment, allowing physicians to tailor their approach to their patients. This is especially important for those with a poorer prognosis, such as cancer that has spread to the brain or those who have L858R mutations."
Dave Fredrickson, executive vice president at AstraZeneca's Oncology Business unit, said: "This approval reinforces Tagrisso as a backbone therapy in EGFR-mutated lung cancer and acknowledges its important role, as monotherapy or with chemotherapy, in addressing the high prevalence of this disease in Asian countries and China, specifically."
Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan.
AstraZeneca shares rose 0.8% to 12,656.00 pence each on Wednesday morning in London.
By Tom Budszus, Alliance News slot editor
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