AstraZeneca Imfinzi Combo Scores FDA Approval As First Immunotherapy Regimen For Biliary Tract Cancer

The FDA approved AstraZeneca plc’s AZN Imfinzi (durvalumab) for locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).
The approval was based on the results from the TOPAZ-1 Phase 3 trial. In an interim analysis of TOPAZ-1, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone.
An estimated one in four patients treated with Imfinzi plus chemotherapy were alive at two years compared to one in 10 (10%) treated with chemotherapy alone.
BTC is a group of rare and aggressive cancers in the bile ducts and gallbladder.
The approval was granted after securing Priority Review and Orphan Drug Designation for Imfinzi in the U.S. in this setting. Regulatory applications are also under review in Europe, Japan, and several other countries based on the TOPAZ-1 results.
China has approved AstraZeneca’s Forxiga (dapagliflozin) to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease.
The approval by China’s National Medical Products Administration is based on positive results from the DAPA-CKD Phase 3 trial.
Price Action: AZN shares are down 0.54% at $60.35 on the last check Tuesday.