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FDA Approves IRESSA® (gefitinib) for Treating Locally Advanced or Metastatic Non-Small Cell Lung Cancer Expressing Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletion or Exon 21 (L858R) Substitution Mutations
On July 13, 2015, the United States Food and Drug Administration (FDA) approved IRESSA (gefitinib) tablets, an epidermal grow factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. The recommended dose of IRESSA tablets is 250 mg orally once daily (QD) taken with or without food. The following are key clinical pharmacology related highlights from the regulatory review of this application:
General Pharmacokinetics and Pharmacodynamics of Gefitinib
Drug Interaction Potential
Use in Specific Populations
Safety and Efficacy
The efficacy and safety of IRESSA was demonstrated in a multicenter, single-arm, open-label clinical trial. The primary endpoint of objective response rate was 50% [95% confidence interval (CI): 40, 60]. The median duration of response was 6 months (95% CI: 5.6, 11.1 months). These results were supported by another randomized trial which reported that a retrospective analysis of the subgroup of 186 EGFR mutation-positive patients suggested an improvement in progression free survival with IRESSA (n=88) compared to carboplatin/paclitaxel (n=98).
The most common adverse events (AEs) were rash, diarrhea, dry skin, nausea, vomiting, cough, and asthenia. Interstitial lung disease, a known AE associated with gefitinib use that is more common in Asian patients, was reported in 1 (1%) Caucasian patient and in 16 (2.6%) Asian patients.
Full prescribing information is available at http://go.usa.gov/3fHuv.
The Office of Clinical Pharmacology (OCP) regulatory reviews for new drugs or biologics are often available for viewing shortly following approval at the Agency's Drugs@FDA website (http://go.usa.gov/3fHuM).
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This Burst was prepared by the Clinical Pharmacology Review Team including Robert Schuck, Clinical Pharmacologist, Genomics and Targeted Therapy Group, and Hong Zhao, Team Leader, Division of Clinical Pharmacology V, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
FDA/Center for Drug Evaluation and Research (CDER)
Office of Translational Sciences
Office of Clinical Pharmacology
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