Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Daiichi Sankyo Reports Vemurafenib NDA

By Drug Discovery Trends Editor | May 14, 2011

Daiichi Sankyo reported that applications for market approval for vemurafenib for the treatment of metastatic melanoma to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Vemurafenib is an oral, novel drug that targets the oncogenic BRAF mutation present in about half of melanoma cancers and about eight percent of all solid tumors.

Genentech, a member of the Roche Group submitted a New Drug Application for vemurafenib (RG7204, PLX4032) to the U.S. Food and Drug Administration (FDA). Roche submitted a Marketing Authorization Application to the European Medicines Agency (EMA) . 

A pre-marketing application for approval for a companion diagnostic test has been submitted in the U.S.; the test also will be registered in Europe. In April 2011, Daiichi Sankyo acquired Plexxikon, which discovered and is co-developing vemurafenib with Roche. Daiichi Sankyo will co-promote vemurafenib in the United States with Genentech under Plexxikon’s co-promotion agreement with them.

 “The NDA submission to FDA for vemurafenib only six years after its discovery reflects Plexxikon’s highly efficient research platform to identify unique molecules as well as the team’s strategic approach to early development,” said Glenn Gormley, MD, PhD, chief science officer, and president, Daiichi Sankyo Pharma Development.
 

Release Date: May 11, 2011
Source: Daiichi Sankyo   


Filed Under: Drug Discovery

 

Related Articles Read More >

Lokavant’s Spectrum v15 uses AI to cut trial-feasibility modeling from weeks to minutes
Prime time for peptide-based drug discovery 
Why smaller, simpler molecular glues are gaining attention in drug discovery
Glass vial, pipette and woman scientist in laboratory for medical study, research or experiment. Test tube, dropper and professional female person with chemical liquid for pharmaceutical innovation
Unlocking ‘bench-to-bedside’ discoveries requires better data sharing and collaboration
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE