(RTTNews) - Thursday, Abraxis BioScience, Inc. (ABII:
News ), a biotechnology company, announced that the Food and Drug Administration has granted orphan drug designation to chemotherapy agent Abraxane for Injectable Suspension for the treatment of pancreatic cancer as well as stage IIB-IV melanoma.
The FDA approved Abraxane for Injectable Suspension in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
Lonnie Moulder, President and Chief Executive Officer said,"As we advance our pivotal clinical trials of Abraxane in pancreatic cancer and melanoma, we look forward to the potential of bringing a new treatment option to patients with these difficult to treat cancers."
Pancreatic cancer and metastatic melanoma can be particularly hard to treat cancers. This year alone, more than 42,000 people are expected to be diagnosed with pancreatic cancer in the United States. Many patients are diagnosed with pancreatic cancer after their disease has spread and more than 35,000 people annually will die from the disease.
Enrollment is ongoing in a Phase III study that will evaluate Abraxane plus gemcitabine versus gemcitabine alone as a first line therapy for advanced metastatic pancreatic cancer, Abraxis said.
Melanoma is an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year. Melanoma is the leading cause of skin cancer death and the current five-year survival rate for patients with advanced stage melanoma is 25%. A phase III registration study comparing Abraxane to dacarbazine in the treatment of stage IV chemotherapy naïve melanoma patients is actively enrolling. Abraxis also continues to study the potential of Abraxane in a variety of tumor types.
ABII closed Thursday's regular trading at $33.15 down $0.35 or 1.04% on a volume of 35,694 shares on the Nasdaq. In the after hour trading, the stock price increased to $33.434 up $0.29 or 0.87%.
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by RTT Staff Writer
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