FDA Expands Approval for Celgene's Injectable Cancer Drug
- Thu, 10/18/12 - 10:47am
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The FDA approved Abraxane® (paclitaxel protein-bound particles for injectable suspension) in combination with carboplatin as a first-line treatment of locally advanced or metastatic non-small cell lung cancer. The drug, marketed by Celgene Corporation, is intended for patients who are not candidates for curative surgery or radiation therapy.
In 2005, the FDA approved paclitaxel protein-bound particles for injectable suspension to treat patients with metastatic breast cancer who had failed treatment with combination chemotherapy.
In a phase 3, multicenter, randomized, open-label study, patients who took paclitaxel protein-bound particles for injectable suspension plus carboplatin had a higher overall response rate (41%) compared with those who took paclitaxel (24%) for squamous cell carcinoma. There was also a higher response rate for patients with large cell carcinoma (33% vs 15%). The groups had similar overall response rates for patients with carcinoma/adenocarcinoma (26% vs 27%).
Common adverse reactions (found in at least 20% of patients) associated with paclitaxel protein-bound particles for injectable suspension to treat non-small cell lung cancer included anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea and fatigue.
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