Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Roche’s EU Accelerated Assessment Bid For Tumor Agnostic Entrectinib Backfires

Executive Summary

A decision to yoke together two indications in one EU accelerated assessment filing for the anticancer has backfired on Roche and left the product at even more of a disadvantage compared with Bayer’s Vitrakvi in the tumor-agnostic setting.

You may also be interested in...



NICE Gives Landmark Nod To Bayer's Vitrakvi

Vitrakvi is the first in a new generation of tumor-agnostic drugs to be made available on the NHS after Bayer and NICE finally reached agreement over pricing and access while more data is collected on its clinical effectiveness.

Bayer's Vitrakvi Is EU’s First Tumor-Agnostic Treatment

The German group's cancer drug is the first to be approved for use in Europe for a wide range of tumors. The principal challenge now is to find eligible patients.

Novartis’s Zolgensma Loses EU Accelerated Assessment

Companies pleased at gaining an EU accelerated assessment for a product should be aware that the agency offers no guarantee that they will get to keep it. Novartis’s Zolgensma is one of seven drugs whose review the EMA has taken off the fast track.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1132082

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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