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

Genentech’s Tecentriq Should Keep Its Accelerated Approval In Breast Cancer For Now, ODAC Says

Executive Summary

Although US FDA panelists said that ideally a new confirmatory trial would be conducted in the same triple-negative breast cancer population, they acknowledged the sponsor’s feasibility concerns and suggested instead that the IMpassion132 trial, expected to report in 2023, might suffice.

You may also be interested in...



In-Person US FDA Meetings Returning? Agency Will Support Those Events At HQ

A workshop broadcast from White Oak was a shift from the fully virtual meetings held since the height of the COVID-19 pandemic and may be a step toward once again staging public events there.

Keeping Track: US FDA Approves Korsuva, Skytrofa And Comirnaty, But Tecentriq Loses TNBC Indication

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keytruda TNBC Approval Now More Likely, But Data Is Bad News For pCR Surrogate Endpoint

Merck unveiled event-free survival results for Keytruda in triple-negative breast cancer following failure earlier this year to gain approval on a surrogate endpoint.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS144230

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