FDA Approves AstraZeneca’s Imfinzi for Biliary Tract Cancer
Imfinzi, a checkpoint inhibitor developed by AstraZeneca, has been approved by the FDA as the first immunotherapy for biliary tract cancer (BTC), a rare and aggressive form of cancer with few treatment options. Imfinzi (durvalumab) has been approved by the Food and Drug Administration for the treatment of locally advanced or metastatic biliary tract cancer in adults in combination with gemcitabine/cisplatin chemotherapy, extending Imfinzi’s use beyond lung cancer for the first time.
The approval follows the TOPAZ-1 trial, which demonstrated that adding Imfinzi to standard first-line chemotherapy for BTC...