Bevacizumab (Avastin) Plus Chemotherapy for First-Line Lung Cancer Therapy in EU
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in EU
http://www.medscape.com/viewarticle/562633
(2007) burt I may have forgoteen to post it.
Bevacizumab (Avastin) Plus Chemotherapy for First-Line Lung Cancer Therapy
in EU
On August 24, the European Commission approved a new indication for
bevacizumab intravenous infusion (Avastin, Roche), allowing its use with
platinum-based chemotherapy for the first-line treatment of advanced
non–small cell lung cancer (NSCLC).
NSCLC is usually diagnosed at an advanced stage, leaving patients with a
life expectancy of 8 to 10 months. According to a company news release,
bevacizumab is the only first-line therapy to have shown improved survival
benefits beyond 1 year in this population.
Approval of the indication was based in part on data from a phase 3 US
study (E4599) of 878 chemotherapy-naive patients, showing that the
addition of 15 mg/kg bevacizumab every 3 weeks to chemotherapy increased
overall survival by 25% compared with chemotherapy alone (12.3 vs 10.3
months; hazard ratio, 0.80; 95% confidence interval, 0.68 – 0.94). Adverse
events most commonly reported in bevacizumab-treated patients included
hypertension (5.6%), dyspnea (5.6%), fatigue (5.1%), and proteinuria
(4.2%); 2.3% of patients developed pulmonary hemorrhage/hemoptysis
compared with 0.5% of those receiving chemotherapy alone (related deaths,
7 vs 1).
These data were supported by findings from the international phase 3
Avastin in Lung (AVAiL) study of more than 1000 patients, showing that the
addition of 7.5 or 15 mg/kg bevacizumab to cisplatin/gemcitabine increased
progression-free survival by 20% to 30% compared with chemotherapy alone.
Bevacizumab previously was approved for this indication by the US Food and
Drug Administration in October 2006; additional US indications include
first- and second-line treatment of metastatic colorectal cancer.
Previously approved European indications include use for the first-line
treatment of metastatic colorectal and breast cancer.