NMPA Nods AstraZeneca's Chemotherapy Treatment

Imfinzi (durvalumab), manufactured by AstraZeneca, has been licensed in China for the first-line treatment of adults with locally advanced or metastatic biliary tract cancer (BTC) in conjunction with chemotherapy (gemcitabine and cisplatin).The approval by China’s National Medical Products Administration (NMPA) was based on the primary results from the TOPAZ-1 phase III trial published in the New England Journal of Medicine Evidence, as well as a prespecified exploratory analysis of an additional cohort of patients in China, as per pharmabiz.BTC is a rare and severe kind of cancer that develops in the bile ducts (cholangiocarcinoma) and gallbladder. Each year, an estimated 211,000 new individuals are diagnosed with gallbladder and biliary tract cancer, with China accounting for roughly one-fifth of those diagnosed.Shukui Qin, MD, president of Nanjing Tianyinshan Hospital of China Pharmaceutical University and national leading principal investigator of the trial in China, said: "Over the past decade, there has been little progress in the treatment of advanced biliary tract cancer. However, the successful results of the TOPAZ-1 trial confirmed that durvalumab plus routine chemotherapy has statistically significant and clinically meaningful overall survival and progression-free survival benefits for these patients. This approval provides a new and better option for the treatment of these patients in China.”Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said: “With this approval for Imfinzi plus chemotherapy, physicians will now be able to offer this global standard-of-care treatment to patients in China, where nearly one in five patients with biliary tract cancer is diagnosed. This important milestone underscores our commitment to bring innovative medicines that transform survival outcomes to people across the globe living with aggressive gastrointestinal tumours such as biliary tract cancer.”