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Abraxane (Paclitaxel) Meets Primary Endpoint in Phase III Metastatic Melanoma Study

Survival improved versus standard chemotherapy (Oct. 2)

On October 2, Celgene International Sàrl, a subsidiary of Celgene Corporation, announced results from its phase III, randomized, international study (CA033) of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) in chemotherapy-naïve patients with metastatic melanoma. In the study, the primary endpoint was met, with abraxane-treated patients demonstrating a statistically significant improvement in progression-free survival compared with patients treated with dacarbazine (DTIC) chemotherapy.

The safety profile of Abraxane observed in the CA033 study is consistent with other Abraxane pivotal clinical trials. Data from this study will be presented at the Society for Melanoma Research (SMR) Congress in Los Angeles in November. Future regulatory and clinical strategies are being reviewed in light of these results.

The CA033 study is a Celgene-sponsored, open-label, controlled, randomized trial comparing Abraxane with standard chemotherapy (DTIC) in patients with metastatic melanoma. DTIC is the only chemotherapy approved since 1975 by the FDA for metastatic melanoma. In the study, 529 chemotherapy-naïve patients were randomly assigned to receive either Abraxane (150 mg/m2 weekly for 3 out of 4 weeks) or DTIC (1,000 mg/m2 every 3 weeks). The primary study endpoint was independently assessed progression-free survival. Secondary endpoints included overall survival, response rate, disease control, safety, and tolerability.

Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should include an anthracycline unless clinically contraindicated.

For more information, visit the Celgene Web site.

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