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

EU Indication Restricted For Novartis's Newly Approved Piqray

Patients Previously Treated With CDK 4/6 Inhibitors Are Excluded

Executive Summary

Piqray is now approved for use in almost 50 countries but not only did the novel drug from Novartis for advanced breast cancer take longer to be approved in the EU than in the US, its indication is narrower in the EU. This is the first of two articles based on the European public assessment report for the PIK3 inhibitor.

You may also be interested in...



Turalio: Why The EU Said No To The US-Approved Drug

Not everyone reviewing Daiichi Sankyo’s EU marketing application for Turalio agreed that the potential tenosynovial giant cell tumor treatment shouldn't be approved.

Piqray: What EU Regulators Saw And What They Wanted

The European public assessment report for Novartis's advanced breast cancer therapy, Piqray (alpelisib), includes some interesting insights into what EU regulators are looking for in drug company clinical trials. 

EU Decision Thwarts Novartis's Near-Term Piqray Ambitions

Novartis seems to have accepted the fact that the indication granted for Piqray in the EU means there is little scope for the advanced breast cancer drug to be used in markets such as the UK.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS142700

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