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


Crypto Whales Are Loading Up — Are You?

New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.


  • The FDA approved AstraZeneca plc’s (NASDAQ: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.

Crypto Whales Are Loading Up — Are You?

New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.


ENTER TO WIN $500 IN STOCK OR CRYPTO

Enter your email and you'll also get Benzinga's ultimate morning update AND a free $30 gift card and more!

Posted In: BiotechLarge CapNewsHealth CareGeneralBriefs