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

FDA Approves Tarceva in Second-Line Tx

  • Roy S. Herbst, MD, PhD
Mar 1, 2005
Volume: 
14
Issue: 
3
  • Lung Cancer, Lung Cancer

ROCKVILLE, Maryland—The Food and Drug Administration
(FDA) has approved Tarceva tablets
(erlotinib, OSI Pharmaceuticals) as a
single-agent treatment for patients
with locally advanced or metastatic
non-small-cell lung cancer (NSCLC)
whose disease has continued to
progress despite other therapies, including
at least one prior chemotherapy
regimen. The FDA granted marketing
approval on the basis of
increased survival findings in the
Tarceva-treated arm of a phase III trial
in patients who had received second-
or third-line therapy for advanced NSCLC. The primary endpoint
of the study was overall survival.
Secondary endpoints included
progression-free survival and tumor
response rate.

Tarceva, developed by OSI and
distributed by Genentech, is an epidermal
growth factor receptor (EGFR)
inhibitor, and it is the first of the class
to demonstrate a survival advantage
for advanced NSCLC in a phase III
trial. However, two large, randomized
studies of Tarceva given concurrently
with doublet platinum-based
chemotherapy in previously untreated
advanced NSCLC failed to show clinical benefit, and the drug is not
recommended for such use.

The pivotal study involved 731 patients
with locally advanced or metastatic
NSCLC in a randomized,
double-blind, placebo-controlled
trial conducted in 17 countries. Patients
were randomized 2:1 to receive
Tarceva 150 mg or placebo, administered
orally once daily until disease
progression or unacceptable toxicity.

Survival, progression-free survival,
and tumor response all proved significant
in favor of Tarceva (P < .001).
Median survival, evaluated in an intent-to-treat population, was 6.7
months for Tarceva vs 4.7 months for
placebo. Median progression-free survival
was 9.9 vs 7.9 weeks, respectively,
and the Tarceva-treated patients had a tumor response rate of 8.9% vs
0.9% for placebo. One-year survival
was 31.2% in the treatment group vs
21.5% for the control patients, and
median duration of response was 34.3
vs 15.9 weeks, respectively.

EGFR status was not part of the
study protocol, and survival was seen
in a broad range of patients. Survival
among EGFR-positive patients was
looked at retrospectively, however.
Among the 238 patients with a known
EGFR status, the 78 EGFR-positive
Tarceva-treated patients had a better
survival rate than the 49 EGFR-positive
placebo patients. Tarceva did not
appear to affect survival in the EGFRnegative
subgroup (HR = 1.01). A
survival benefit due to Tarceva in the
EGFR-negative subgroup cannot be
excluded, however, because the confidence
intervals for the EGFR-positive,
-negative, and unmeasured
subgroups are wide and overlap (see
Table 1).

The most common adverse reactions
in patients receiving Tarceva
were rash and diarrhea.

Related Articles

  • Epacadostat/Durvalumab Combo Well Tolerated in Solid Tumor Trial
  • Antibiotics Reduced Efficacy of Checkpoint Inhibitors in RCC, NSCLC
  • Systemic Treatment Options for Brain Metastases from Non–Small-Cell Lung Cancer
  • New Option in NSCLC With IL-15 Agonist Plus Immune Checkpoint Inhibition
  • Durable Responses, Longer Survival Seen in NSCLC With Nivolumab at 5 Years

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.