• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Tarceva (erlotinib, OSI 774)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Tarceva (erlotinib, OSI 774)

  • Profile

Profile

Contact Information

Contact: Genentech (Roche)
Website: https://www.gene.com/

Currently Enrolling Trials

    Show More

    General Information

    Tarceva (erlotinib) is a human epidermal growth factor receptor type 1/epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor. While the complete mechanism of action is not entirely understood, the drug appears to impede cell-cell signaling pathways, which have been implicated in rapid cell division and survival. Overactivation of these pathways is thought to be central to tumor growth and metastasis.

    It is specifically indicated as monotherapy to treat non-small cell lung cancer in patients who have failed to respond or has ceased responding to at least one round of chemotherapy. It is not indicated as a first-line therapy. Results from two, multicenter, placebo-controlled, randomized, phase 3 trials conducted in first-line patients showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy regimens.

    Mechanism of Action

    Tarceva (erlotinib) is a human epidermal growth factor receptor type 1/epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor. While the complete mechanism of action is not entirely understood, the HER1 and EGFR receptors are directly involved in inter-cellular signaling in systems governing cell division and proliferation. By inhibiting the function of these receptors, which are highly active and often over-expressed in rapidly dividing tumor cells, Tarceva is thought to limit tumor cells' ability to divide and metastasize and may help to initiate pathways of apoptotic cell death.

    Side Effects

    Adverse events associated with the use of Tarceva may include, but are not limited to, the following:

    • Rash
    • Diarrhea
    • Anorexia
    • Stomatitis
    • Pruritus
    • Infection

    In addition to these events, infrequent serious interstitial lung disease (ILD) has been observed, including fatalities. ILD incidence in the trial which formed the basis of FDA approval was the same for both placebo and Tarceva groups (0.8 percent of patients). Most cases were associated with confounding or contributing factors. Tarceva use should be suspended pending evaluation on the appearance of new pulmonary symptoms and discontinued upon diagnosis of ILD.

    Dosing/Administration

    Tarceva is administered as an oral tablet, with a recommended dosage of 150 mg once daily at least one hour before or two hours after eating. Patients experiencing significant adverse reactions should reduce dosage as appropriate in 50 mg decrements.

    Clinical Trial Results

    FDA approval of Tarceva was a double-blind, placebo-controlled clinical studies enrolling a combined total of 731 subjects with confirmed locally advanced or metastatic NSCLC after failure of at least one chemotherapy regimen. The trial randomized subjects at a 2:1 ratio to receive Tarceva (n=488) or placebo (n=243) orally once daily until evidence of disease progression or unacceptable toxicity. In the intent to treat population, Tarceva was found to significantly improve one-year survival time, progression-free tumor response and response duration and median overall response duration. In subsets of patients with EGFR- positive tumors and patients who never smoked, the drug appeared to carry improved efficacy.

    Results from two, multicenter, placebo-controlled, randomized trials in over 1,000 patients investigating the drug as a first-line adjuvant to standard platinum-based chemotherapy regimens (carboplatin and paclitaxel or gemcitabine and cisplatin) indicated that patients with locally advanced or metastatic NSCLC showed no clinical benefit in terms of tumor response or survival benefit with the concurrent administration of TARCEVA versus chemotherapy alone.

    Additional Information

    For additional information regarding Tarceva or non-small cell lung cancer, please web site contact the Tarceva website.

     

    Approval Date: 2004-11-01
    Company Name: Genentech, OSI Pharmaceuticals
    Back to Listings

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

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

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing