We've noticed that you're using an ad blocker

Our content is brought to you free of charge because of the support of our advertisers. To continue enjoying our content, please turn off your ad blocker.

It's off now Dismiss How do I disable my ad blocker?
❌

How to disable your ad blocker for our site:

Adblock / Adblock Plus
  • Click on the AdBlock / AdBlock Plus icon on the top right of your browser.
  • Click “Don’t run on pages on this domain.” OR “Enabled on this site.”
  • Close this help box and click "It's off now".
Firefox Tracking Prevention
  • If you are Private Browsing in Firefox, "Tracking Protection" may casue the adblock notice to show. It can be temporarily disabled by clicking the "shield" icon in the address bar.
  • Close this help box and click "It's off now".
Ghostery
  • Click the Ghostery icon on your browser.
  • In Ghostery versions < 6.0 click “Whitelist site.” in version 6.0 click “Trust site.”
  • Close this help box and click "It's off now".
uBlock / uBlock Origin
  • Click the uBlock / uBlock Origin icon on your browser.
  • Click the “power” button in the menu that appears to whitelist the current website
  • Close this help box and click "It's off now".
  • ONCOLOGY
  • News
  • Blogs
  • Topics
  • Hematology
  • Image IQ
  • Podcasts
  • Videos
  • Slideshows
  • Conferences

Modern Medicine Network
  • Login
  • Register
Skip to main content
Modern Medicine Network
  • Login
  • Register
Menu
User
Home
  • ONCOLOGY
  • News
  • Blogs
  • Topics
  • Hematology
  • Image IQ
  • Podcasts
  • Videos
  • Slideshows
  • Conferences

SUBSCRIBE: Print / eNewsletter

ODAC Advises Changes to Clinical Study Designs for First-Line Hormonal Treatments of Metastatic Breast Cancer

Oct 1, 2001
Volume: 
10
Issue: 
10
  • Breast Cancer

BETHESDA, Maryland—Members of the Oncologic Drugs Advisory
Committee (ODAC) have recommended a change in the endpoint the Food and Drug
Administration (FDA) uses to evaluate hormonal agents as first-line therapy for
metastatic breast cancer. The panel considered the issue of revising the design
of hormonal therapy clinical trials at the agency’s request.

A key ODAC recommendation, made by a 10-to-3 vote, was that in making
drug-approval decisions, FDA should replace response rate, its long-time
endpoint for anticancer hormonal agents in the first-line setting, with time to
tumor progression.

FDA has accepted response rate as an endpoint since 1976, when it approved
the first hormonal anticancer agent, megestrol acetate (Megace), as a
palliative treatment for advanced breast cancer. One year later, FDA cleared
tamoxifen (Nolvadex) for marketing, again relying on response rate findings.

For more than 2 decades, FDA has evaluated breast cancer hormonal agents on
whether they were noninferior (no worse than) or superior to an approved drug,
usually tamoxifen, used as a comparison.

Generally, FDA has interpreted non-inferiority to mean ruling out that a new
drug has a response rate that is 10% lower than the comparison agent. Since
1995, FDA has approved toremifene (Fareston), anastrozole (Arimidex), and
letrozole (Femara) using this standard for evaluation. The agency has required
sponsors to submit data on survival and time to progression as secondary
endpoints.

During a half day of deliberations, ODAC members also:

  • Voted 12 to 1 that non-inferiority to tamoxifen no longer be
    considered an acceptable basis for approval. If tamoxifen is the comparator,
    demonstration of superiority should be required.
  • Voted 10 to 3 against designation of a single approved drug as the
    only acceptable comparator in future clinical trials. FDA noted that choice of
    a comparator will determine whether superiority or non-inferiority is an
    appropriate trial design and analysis.
  • Advised FDA 9 to 4 that data do not suggest that one class of
    hormonal agents is clearly superior to another.

In urging a switch from response rate to a time-to-progression endpoint in
trials of hormonal agents, ODAC members noted that large numbers of patients
would be needed to adequately measure noninferiority using the new standard,
but that patients with bone-only disease could be included. Also, the endpoint
of time to progression could reflect the potential benefit of prolonged stable
disease, the panel said.

Pages

  • 1
  • 2
  • next ›
  • last »

Related Articles

  • OncoMasTR Assay May Help Some Breast Cancer Patients Avoid Chemo
  • RAD51 Linked With PARP Inhibitor Resistance in BRCA-Mutated Breast Cancer
  • HER2+ Breast Cancer Subtypes Resistant to TKIs Through Differing Mechanisms
  • COUNTERPOINT: LHRH Agonists vs Ovarian Ablation for Suppression of Ovarian Function in Premenopausal Breast Cancer Patients
  • POINT: LHRH Agonists vs Ovarian Ablation for Suppression of Ovarian Function in Premenopausal Breast Cancer Patients

Resource Topics rightRail

  • Resource Topics
  • Partner Content
Breast Cancer
Lung Cancer
Prostate Cancer
Colorectal Cancer
Melanoma
Cutaneous T-Cell Lymphomas: Mycosis Fungoides and Sézary Syndrome
3 Keys to Success in the Oncology Care Model

Current Issue

Oncology Vol 32 No 4
Apr 15, 2018 Vol 32 No 4
Digital Edition
Subscribe
Connect with Us
  • Twitter
  • Facebook
  • LinkedIn
  • RSS
Modern Medicine Network
  • Home
  • About Us
  • Advertise
  • Advertiser Terms
  • Privacy statement
  • Terms & Conditions
  • Editorial & Advertising Policy
  • Editorial Board
  • Contact Us
Modern Medicine Network
© UBM 2018, All rights reserved.
Reproduction in whole or in part is prohibited.