In Vivo 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


GSK gets EU fast track for MEK & BRAF/MEK in melanoma

This article was originally published in Scrip

Executive Summary

GlaxoSmithKline has submitted a marketing authorization application to the European Medicines Agency ( EMA) for the in-licensed novel MEK inhibitor trametinib as monotherapy and in combination with its BRAF inhibitor dabrafenib to treat metastatic melanoma. The agency's Committee for Medicinal Products for Human Use ( CHMP) has granted the company's request for accelerated assessment, meaning that it will have a maximum review time of 150 days, versus the standard timeline of up to 210 days.



Related Companies




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