Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced results of 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 patients receiving ABRAXANE demonstrating a statistically significant improvement in progression-free survival compared to patients receiving 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 2012 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 study comparing ABRAXANE to standard chemotherapy, DTIC, in patients with metastatic melanoma. DTIC is the only chemotherapy approved since 1975 by the U.S. Food and Drug Administration for metastatic melanoma. In the study, 529 chemotherapy-naïve patients were randomized to receive either ABRAXANE (150mg/m2 weekly for 3 out of 4 weeks) or DTIC (1000 mg/m2 every three weeks). The primary study endpoint was independently-assessed progression free survival. Secondary endpoints included overall survival, overall response rate and disease control, safety and tolerability.
These results are from an investigational study. ABRAXANE® is not approved for the treatment of metastatic melanoma.
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Important Safety Information
WARNING - NEUTROPENIA
WARNINGS AND PRECAUTIONS
Use in Pregnancy: Pregnancy Category D
Use in Men:
ADVERSE REACTIONS - Randomized Metastatic Breast Cancer Study
Post-Marketing Experience with ABRAXANE and other Paclitaxel Formulations
USE IN SPECIFIC POPULATIONS
DOSAGE AND ADMINISTRATION
Please see full Prescribing Information, including Boxed WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. When melanoma is diagnosed early, it is generally a curable disease. However, when it spreads to other parts of the body, it is the deadliest and most aggressive form of skin cancer. A person with metastatic melanoma typically has on average a short life expectancy that is measured in months. According to the World Health Organization, approximately 132,000 new cases of melanoma are diagnosed each year globally. The incidence of melanoma has increased ten-fold over the past 50 years, and has steadily increased since the 1970s. The American Cancer Society estimates there will be more than 76,000 new cases of melanoma and nearly 9,200 melanoma deaths this year in the United States.
About Celgene International Sàrl
Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.
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