The drug was previously approved for use only in patients who did not respond to chemotherapy.
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The U.S. Food and Drug Administration approved AstraZeneca Plc’s drug, Iressa, as a first-line treatment for a common form of lung cancer.
The newly approved drug will act as an inhibitor and prevent the production of proteins that encourage the growth of cells that carry the mutated genes. The current approval is intended for the treatment of patients with NSCLC and the most common types of EGFR mutations, including exon 19 deletions and exon 21 L858R substitution gene mutations. Though more common among men, the number of deaths from lung cancer in women is rising. The test rapidly identifies EGFR mutation status through a tumour tissue sample, in order to guide the use of IRESSA in the treatment of patients with metastatic NSCLC. More than 220,000 Americans are likely to be diagnosed with lung cancer this year, and the disease will kill an estimated 158,000 people, the National Cancer Institute projects.
The new drug is called gefitinib, under the brand name Iressa which is approved in 91 countries worldwide, the company said.
The FDA approval of Iressa is based on data from the IFUM (IRESSA Follow-Up Measure) clinical trial which showed an Objective Response Rate (ORR) of 50 and 70% (BICR and investigators, respectively) with a median Duration of Response (DOR) of 6 and 8.3 months.
Serious adverse events associated with gefitinib include interstitial lung disease, liver damage, gastrointestinal perforation, severe diarrhea and ocular disorders.
AstraZeneca has partnered with QIAGEN to provide the therascreen® EGFR companion diagnostic test for IRESSA in the US.
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The FDA said on Tuesday the certification was determined on end product from an effort of 106 sufferers along with prior with no treatment non-small cubicle lung cancer.
