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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Janssen’s Imbruvica Wins Canadian Approval for Chronic Lymphocytic Leukemia

Janssen’s Imbruvica Wins Canadian Approval for Chronic Lymphocytic Leukemia

Janssen logo
December 3, 2014

Health Canada has approved Johnson & Johnson subsidiary Janssen’s cancer drug Imbruvica for treating chronic lymphocytic leukemia.

Imbruvica (ibrutinib) was cleared as a first-line treatment for patients with a 17p deletion in a gene that tends to lead to poor treatment outcomes. It also will be indicated as a second-line treatment for patients with all forms of CLL, including those with that deletion.

The approval was based on a Phase III trial evaluating the drug against GlaxoSmithKline’s Arzerra (ofatumumab) that showed Imbruvica generally led to a 78-percent risk reduction of disease progression or death by any cause. It also led to positive outcomes in overall survival, the company said Monday.

Unlike most first-line CLL chemotherapy treatments, Imbruvica can be taken once per day at home and works by blocking a compound that allows affected white blood cells to grow and spread.

The drug should now be available in Canada, said Janssen spokeswoman Kate Hanna. The company is in talks with Health Canada regarding a mantle cell lymphoma indication.

Imbruvica has been approved in Europe for CLL and for mantle cell lymphoma, and in the U.S. as a second-line treatment for most CLL patients and a first-line treatment for those with the 17p deletion. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 26Jan

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

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

  • 11Feb

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

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Eli Lilly logo

    Lilly’s Monoclonal Antibody Could Prevent COVID-19 in the Elderly

  • CE mark

    Fluidigm Gains CE Mark for Saliva-Based Assay for COVID-19

  • Regeneron logo

    Regeneron’s Antibody Cocktail Shows Efficacy as COVID-19 Treatment

  • Mobile apps client cellphone cell phone

    FDA to Review Berkshire’s 510(k) Submission for Remote Drug-Delivery System

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 – Fax 703.538.7676 – Toll free 888.838.5578

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