ABRAXANE(R) Receives Orphan Drug Status For The Treatment Of Pancreatic Cancer And Stage IIB-IV Melanoma

Main Category: Pancreatic Cancer
Also Included In: Melanoma / Skin Cancer
Article Date: 08 Nov 2009 - 0:00 PST

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Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, announced that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation to the chemotherapy agent ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of pancreatic cancer as well as stage IIB-IV melanoma.

"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," said Lonnie Moulder, President and Chief Executive Officer.

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.i ii 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.

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 percent. iii A phase III registration study comparing ABRAXANE to dacarbazine (or DTIC) in the treatment of stage IV chemotherapy naïve melanoma patients is actively enrolling.

Abraxis continues to study the potential of ABRAXANE in a variety of tumor types.

About ABRAXANE

ABRAXANE® is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience's proprietary nab® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma and pancreatic.

The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 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. Prior therapy should have included an anthracycline unless clinically contraindicated. The U.S. Food and Drug Administration granted orphan-drug designation for ABRAXANE for the treatment of pancreatic cancer in September 2009 and stage IIb to IV melanoma in October 2009. For the full prescribing information for ABRAXANE please visit http://www.abraxane.com.

i Korn, EL et al. Meta-Analysis of Phase II Cooperative Group Trials in Metastatic Stage IV Melanoma to Determine Progression-Free and Overall Survival Benchmarks for Future Phase II Trials. J Clin Oncol. 26:527-534 (2008).

ii American Cancer Society. Cancer Facts & Figures 2009. Atlanta: American Cancer Society; 2009. Available at http://www.cancer.org/docroot/STT/STT_0.asp.

iii American Cancer Society. Cancer Facts & Figures 2009. Atlanta: American Cancer Society; 2009. Available at http://www.cancer.org/docroot/STT/STT_0.asp.

Source
Abraxis BioScience, Inc.