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

Keeping Track: Accelerated Approval Wins (Padcev+Keytruda) And Losses (Imbruvica To Shed MCL, MZL Claims)

Executive Summary

The latest drug development news and highlights from the Pink Sheet's US FDA Perfomance Tracker.

You may also be interested in...



Seagen, Astellas Data Support Broader Indication For Padcev/Keytruda Combo

With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval.

AbbVie/J&J Withdrawal Of Imbruvica Indications Clears Space For Competitors

The BTK inhibitor’s exit from MCL and MZL after lackluster Phase III confirmatory trial results gives AstraZeneca’s Calquence and BeiGene’s Brukinsa a potential shot at claiming the space.

Merck’s Keytruda And Seagen’s Padcev Become First PD-1/ADC Combo To Win US Approval

The blockbuster PD-1 inhibitor and antibody-drug conjugate will be used to treat a subset of first-line urothelial carcinoma patients considerably widening Padcev’s market, but rates of peripheral neuropathy with the combination have left some analysts concerned.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148021

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