We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » AFTER FIVE YEARS, GLEEVEC PATIENTS SEE ALMOST 90 PERCENT SURVIVAL RATE

AFTER FIVE YEARS, GLEEVEC PATIENTS SEE ALMOST 90 PERCENT SURVIVAL RATE

June 15, 2006

Almost 90 percent of patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) were alive five years after they began receiving Gleevec (imatinib), drugmaker Novartis announced at the recent 2006 annual meeting of the American Society of Clinical Oncology.

The 89.4 percent survival rate in the Phase III trial, which was started in June 2000, includes deaths from all causes, but only 4.6 percent of the patients died from causes related to their leukemia, Novartis said. Moreover, the yearly risk of progressing to advanced disease continued to decline to 0.6 percent in the fifth year. Before Gleevec became available, about half of all patients progressed to the more advanced stages of Ph+ CML after only three to five years, with poor prospects for survival.

"Gleevec is a targeted therapy," Geoffrey Cook of Novartis Oncology told FDAnews. The target is Bcr-Abl tyrosine kinase, which is one of the causes of the disease and is in turn caused by the Philadelphia chromosome genetic defect, named after two Philadelphia-based researchers who first identified it in the 1960s. The therapy "hits [the target] very well, with a very high binding ability," Cook said.

Gleevec, known as Glivec in some other countries, was formerly known as STI571. The International Randomized Interferon versus STI571 (IRIS) study is an open-label Phase III clinical trial enrolling 1,106 newly diagnosed patients with Ph+ CML in chronic phase in 177 centers across 16 countries. The results of the trial were so impressive early on that the company decided to break the original blind the study was operating under and make Gleevec available to patients who had been in the control group.

KEYWORDS FDAnews Drug Daily Bulletin

    Upcoming Events

    • 11Oct

      GMP Quality Management vSummit 2023: Where Quality Meets Risk

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    • 02Nov

      How UDI and UDI Data Can — and Must — Be Used for More Than Just Device Identification

    • 08Nov

      18th Annual FDA Inspections vSummit

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • Potential Penalties Force BMS to Sign Drug Price Negotiation Agreement With CMS

    • Despite AdComm Endorsement, neffy Nasal Spray Alternate for EpiPen Gets CRL

    • Adcomm Votes Down ALS Stem Cell Therapy, Debates Clinical Data vs. Personal Data

    • Reports Allege Philips Withheld Evidence of Ventilator Malfunctions for 11 Years

    The Revised ICH E8: A Guide to New Clinical Trial Requirements

    Learn More
    • Drug Products
      • Quality
      • Regulatory Affairs
      • GMPs
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Device Products
      • Quality
      • Regulatory Affairs
      • QSR
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Clinical Products
      • Trial Design
      • Data Integrity
      • GCP
      • Inspections and Audits
      • Transparency
    • Privacy Policy
    • Do Not Sell or Share My Data
    Footer Logo

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

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing