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 » Roche Gains Priority Review for Tecentriq Combo Treatment in Cancer Patients

Roche Gains Priority Review for Tecentriq Combo Treatment in Cancer Patients

roche.gif
May 9, 2018

The FDA granted priority review for Roche’s Tecentriq (atezolizumab) used in combination with Avastin (bevacizumab), paclitaxel and chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) patients.

Roche’s phase III results — which met its co-primary endpoints of overall and progression-free survival — showed the combination therapy could potentially provide a significant survival benefit in the initial treatment of NSCLC. Its safety profile combination was consistent with the profiles for the individual medicines and no new safety signals were identified.

Tecentriq is already approved by the FDA to treat metastatic NSCLC in patients whose condition progresses during or following platinum-containing chemotherapy and who have progressed on an FDA-approved targeted therapy, if their tumor has epidermal growth factor receptor or anaplastic lymphoma kinase mutations.

View today's stories

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 15Apr

    Five Telltale Signs You’re Ready for an Electronic TMF System

  • 21Apr

    CDER’s Most Significant Guidance Priorities for 2021: Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Bristol Myers Squibb logo

    UK’s NICE Rejects Opdivo and Yervoy Combo for Lung Cancer

  • ClearanceStamp_Orange.gif

    Medtronic Earns De Novo Clearance for AI Colonoscopy System

  • HealthCanada_Logo.gif

    Health Canada Introduces New Reporting Requirements to Reduce Shortages

  • Gilead_Logo.gif

    Gilead Halts Phase 3 Remdesivir Study in High-Risk Nonhospitalized COVID-19 Patients

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