Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • The Pharma 50

Imfinzi with chemotherapy gets FDA priority review for locally advanced or metastatic biliary tract cancer

By Brian Buntz | May 5, 2022

AstraZenecaAstraZeneca (LON:AZN) has announced that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has received Priority Review from FDA when used with chemotherapy in patients with locally advanced or metastatic biliary tract cancer (BTC).

The company had submitted data from the TOPAZ-1 Phase 3 study indicating an improvement in overall survival compared to standard-of-care chemotherapy.

FDA has set a Prescription Drug User Fee Act date for the third quarter of 2022.

Roughly 23,000 people in the U.S. receive a BTC diagnosis annually. Of those, approximately 5% to 15% survive five years after diagnosis.

“People with advanced biliary tract cancer have faced poor outcomes and limited treatment options for too long, and today’s news for the TOPAZ-1 trial underscores the urgency to deliver new, effective therapies in this setting,” said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca: “We are working closely with the FDA to bring the first immunotherapy-based option to patients with this devastating cancer and potentially set a new standard of care with Imfinzi plus chemotherapy.”

An interim analysis of the TOPAZ-1 study showed that Imfinzi plus chemotherapy (gemcitabine plus cisplatin) cut the risk of death by 20% compared to chemotherapy alone.

The data indicated that the combination of Infinzi and chemotherapy led to a 25% reduction in the risk of disease progression or death compared to chemotherapy alone.

In September 2021, AstraZeneca announced that Imfinzi with tremelimumab and platinum-based chemotherapy improved overall survival by 23% and progression-free survival by 28% compared to chemotherapy alone in patients with metastatic non-small cell lung cancer based on the Phase 3 POSEIDON study.


Filed Under: Biologics, Oncology
Tagged With: AstraZeneca, biliary tract cancer, BTC, Imfinzi, TOPAZ-1
 

Tell Us What You Think! Cancel reply

You must be logged in to post a comment.

Related Articles Read More >

Black Diamond Therapeutics
Black Diamond analysis highlights 22 new oncogenic HER2 driver mutations
Novartis
Novartis reveals positive Phase 3 data for tislelizumab plus chemotherapy in esophageal cancer
AstraZeneca/Daiichi-Sankyo
AstraZeneca and Daiichi Sankyo win new breakthrough therapy designation for Enhertu
Black Diamond Therapeutics
Black Diamond Therapeutics slashes workforce by 30% while discontinuing development of BDTX-189

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • The Pharma 50