HealthDay News — The FDA has approved protein-bound paclitaxel (Abraxane, Celgene Corp.) as first-line therapy in combination with the drug carboplatin to treat advanced or spreading non-small cell lung cancer (NSCLC) among people who are not candidates for surgery or radiation therapy, the agency announced in a press release.
Abraxane was first approved in 2005 to treat breast cancer. The FDA extended it’s indication to include NSCLC after results from a large randomized clinical trial involving 1,038 patients with NSCLC showed a significantly higher response rate among those treated with protein-bound paclitaxel plus carboplatin, compared with those who received conventional paclitaxel and carboplatin (33% vs. 25%).
Superior response rates were observed among patients who had squamous-cell tumors (41% vs. 24%) and those with large-cell carcinoma (33% vs. 15%). Response rates for both regimens were equivalent among patients with adenocarcinoma histology (26% vs. 27%).
The most common adverse reactions to the drug were anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea and fatigue — which occured in more than 20% of patients. Serious adverse events occurred in 18% of patients in each treatment arm, the researchers found.
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