• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Celator Pharmaceuticals receives FDA Fast Track for CPX-351 for AML

Celator Pharmaceuticals receives FDA Fast Track for CPX-351 for AML

January 22, 2015
CenterWatch Staff

The FDA granted Fast Track designation for Celator Pharmaceuticals’ CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation facilitates meetings with FDA to discuss all aspects of development to support approval.

It also provides the opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission. In addition, a Fast Track designated product could be eligible for priority review if supported by clinical data at the time of NDA submission.

"We are pleased that FDA has granted Fast Track status for CPX-351 for the treatment of elderly patients with secondary AML," said Scott Jackson, CEO of Celator Pharmaceuticals. "Our ongoing phase III study in these patients has completed enrollment, and we expect induction response rate data to be available in the second quarter of this year, and to have overall survival data, the primary endpoint of the study, in the first quarter of 2016. If our phase III study, comparing CPX-351 to the current standard of care, is successful, the Fast Track designation may provide an added benefit of facilitating the NDA review process."

Upcoming Events

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • TechInnovation-360x240.png

    Pace of Technology Innovation in Trials Could Slow After Pandemic Eases

  • AskTheExperts-360x240.png

    Ask the Experts: Certifying and Maintaining Copies of Original Source Documents

  • Resources-360x240.png

    Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

  • FocusinRed-360x240.png

    Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing