The approval was based on the TOPAZ-1 Phase III trial results, which demonstrated that a combination of Imfinzi and chemotherapy can bring down the risk of death by 20% compared to chemotherapy alone
AstraZeneca secures another FDA approval for Imfinzi. (Credit: D Wells/Wikimedia Commons)
AstraZeneca has received approval from the US Food and Drug Administration (FDA) for the combination of Imfinzi (durvalumab) and chemotherapy for the treatment of locally advanced or metastatic biliary tract cancer (BTC) in adults.
The chemotherapy intended to be used in the combination is gemcitabine plus cisplatin.
The FDA approval for the Imfinzi combination was based on the findings of the TOPAZ-1 phase 3 trial. In the late-stage trial, the Imfinzi and chemotherapy combination was shown to have cut down the risk of death by 20%, when compared to chemotherapy alone.
The trial showed that around one in four, that is 25% patients treated with the AstraZeneca drug combination, were found alive at the end of two years compared to one in 10, that is 10%, treated with only chemotherapy.
Prior to the approval in the biliary tract cancer indication, Imfinzi was given orphan drug designation and priority review by the FDA in the same setting.
Imfinzi is a human monoclonal antibody, which has approvals in the US and other countries for certain types of lung and bladder cancers.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “For the first time, patients in the US with advanced biliary tract cancer have an immunotherapy-based treatment option that meaningfully extends survival and is well-tolerated.
“This approval for Imfinzi and chemotherapy advances our ambition to challenge treatment expectations and transform care for patients with gastrointestinal cancers with high unmet need.”
AstraZeneca is seeking approval for the same drug combination based on the TOPAZ-1 results in Europe, Japan, and other countries.
In a separate announcement, the pharma major said that it has secured approval from China’s National Medical Products Administration (NMPA) for Forxiga (dapagliflozin) for the treatment of chronic kidney disease in adults with and without type-2 diabetes.