Pink Sheet 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

Myeloma BCMA Therapy In Spotlight: EMA Considers Fast Tracking GSK Filing

EU Filing Understood To Be Expected in H1 2020

Executive Summary

The European Medicines Agency is this week deciding whether GlaxoSmithKline’s planned EU marketing application for its BCMA-targeting therapy merits an accelerated assessment.

You may also be interested in...



Ide-Cel & Enhertu Sponsors Keep Fingers Crossed For EMA Fast-Track

Companies are due to learn this week whether the European Medicines Agency will fast-track its review of their soon-to-be-filed EU marketing applications.

EU Accelerated Assessment Tracker

The European Medicines Agency this year is known to have granted ten requests for accelerated assessment of planned EU marketing authorization applications. Nine such requests are known to have been rejected. As 2019 draws to a close, the outcomes of five requests are still unknown.

GSK Files Its BCMA Drug In Multiple Myeloma

GSK has filed its anti-BCMA agent with the FDA after full Phase II DREAMM-2 data showed an overall response rate of 31% in patients with heavily pre-treated multiple myeloma.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141181

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