Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Approval Of Lynparza For Pancreatic Cancer Opens Door For PFS Endpoint In Disease

Executive Summary

AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.

You may also be interested in...



Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza

The latest drug development news and highlights from our US FDA Performance Tracker.

AZ's Lynparza Gets Prostate Cancer Priority Review

The race is firmly on to be the first PARP inhibitor approved for metastatic castration-resistant prostate cancer, with the FDA giving a speedy review to AstraZeneca and Merck & Co's Lynparza just days after granting the same to Clovis Oncology's Rubraca.

Lynparza Gets US OK For Pancreatic Cancer

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS141449

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel