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
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Positive Opinion for Xalkori

By Drug Discovery Trends Editor | July 24, 2012

NEW YORK (AP) – Pfizer Inc. said that a European Union advisory panel recommended that its lung cancer drug Xalkori get conditional marketing approval.

The panel recommended that Xalkori be approved conditionally for use in patients who have already received at least one treatment for lung cancer. The non-binding opinion will be considered by EU regulators. Pfizer said that if Xalkori gets conditional approval, it will be required to submit data from a recently completed clinical trial. Regulators could give the drug full approval after reviewing those results.

Drugs that address unmet medical needs sometimes get conditional approvals so patients can use the products before they get full marketing approval. Xalkori targets cancer linked to a genetic mutation found in less than 7% of non-small cell lung cancer patients.

The U.S. Food and Drug Administration approved Xalkori, or crizotinib, in August as a treatment for non-small cell lung cancer that has advanced locally or spread to other parts of the body. The drug is also approved in Japan, Canada and other countries.

Date: July 20, 2012
Source: Associated Press


Filed Under: Drug Discovery

 

Related Articles Read More >

Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
“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
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE