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 & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • 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

  • 13Jul

    FDA Ad and Promo Enforcement Trends: Past, Present and Future

  • 27Jul

    Applying the Lessons of the Pandemic to Your Upcoming Trial

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FX Receives FDA Clearance for Its FX V135 Shoulder Arthroplasty Platform

  • FDA Recommends Modified COVID-19 Vaccine Boosters Adapted to Omicron BA.4 and BA.5 Subvariants

  • FDA Approves Foundation Medicine’s Companion Diagnostic for Genentech’s Rozlytrek

  • Novartis Pays $100 Million for Mallinckrodt’s Priority Review Voucher

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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing