Latest News - Iressa Status
*** Patients and physicians can obtain the latest information
about Iressa by calling the AstraZeneca Cancer Support Network at 1-866-992-9276
***
FDA
Statement on Iressa (US Food & Drug Administration)
Patient information regarding results of a large clinical trial of
Iressa in patients with NSCLC that failed to show an overall survival
advantage. Patients currently taking Iressa should consult with their
doctors regarding continued use of Iressa. Alternative therapies are available.
Certain subsets of patients may derive benefit from Iressa. The FDA's
evaluation of the recent study results is ongoing. [12/04]
Iressa
(National Cancer Institute)
Updated information on Iressa includes news of a recent trial that
reporting that Iressa (gefitinib) was not associated with a significant
survival improvement in the trial population of lung cancer patients.
Includes links to recent FDA information on Iressa and to a letter from
Astra-Zeneca to prescribing physicians discussing implications of the
trial results. Discusses the FDA approval of Iressa in May 2003, explaining
the clinical trials data (responses and side effects) that resulted in
approval. Includes a link to the full prescribing information for Iressa.
[1/05]
Clinical Research & FDA Approval
Iressa
Approved for NSCLC: An Expert Interview with Alan B. Sandler, MD
(Medscape)
Provides a brief summary of the basis for FDA approval of Iressa
and offers a helpful Q & A with Dr. Alan Sandler to elucidate issues
surrounding Iressa. Registration required for free access to Medscape.
[5/03]
FDA
Drug Approval Summary: Gefitinib (ZD1839; Iressa) Tablets
(The Oncologist)
by Martin H. Cohen et al.
v.8 The Oncologist (August 2003): 303-306
Summarizes the efficacy and safety results of clinical trials relevant
to the approval of gefitinib (ZD1839; Iressa) as monotherapy treatment
for patients with locally advanced or metastatic NSCLC after failure of
both platinum-based and docetaxel therapies. [8/03]
ZD1839
(Iressa): What's In It for the Patient?
(The Oncologist)
by Ronald B. Natale and Susan L. Zaretsky
v.7, Suppl.4 The Oncologist (August 2002): 25-30
Provides an overview of ZD1839 (Iressa), the first of a new class
of epidermal growth factor receptor tyrosine kinase inhibitors. Discusses
the results of two phase II trials that have shown that ZD1839 provides
clinically significant symptom relief for many patients with extensively
pretreated advanced NSCLC. Moreover, this improvement in disease-related
symptoms correlated with improved survival and tumor response. ZD1839
also had an acceptable tolerability profile: most drug-related adverse
events were mild and reversible. Some patients also experienced improved
quality of life, particularly those with a partial response or stable
disease. Concludes that ZD1839 offers a new treatment option providing
meaningful symptom relief for many patients with NSCLC. [8/02]
Iressa
& Treatment of Brain Metastases from NSCLC - Recent MEDLINE Abstracts
(PubMed)
Iressa - Clinical Trials
Iressa
- Clinical Trials (ClinicalTrials.gov)
Iressa - Side Effects
Iressa
Treatment Q & A (CancerBACUP)
Provides basic information on Iressa: how it works, how it is given and
possible side effects. [4/04]
Iressa
& Interstitial Pneumonia - Recent MEDLINE Articles (PubMed)
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