Abraxis BioScience’s chemotherapy agent, ABRAXANE for injectable suspension, has received orphan drug designation from the Office of Orphan Products Development of the FDA. It is intended for the treatment of pancreatic cancer and stage IIB-IV melanoma.
Reportedly, ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using the company’s nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. By wrapping the albumin around the active drug, it can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel.
The company said that pancreatic cancer and metastatic melanoma can be hard to treat cancers. 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.
According to Abraxis, melanoma is a form of skin cancer that affects more than 68,000 people in the US 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 (or DTIC) in the treatment of stage IV chemotherapy naïve melanoma patients, is actively enrolling.
Lonnie Moulder, president and CEO of Abraxis, 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.”
ABRAXANE is currently in various stages of investigation for the treatment of the cancers such as expanded applications for metastatic breast, non-small cell lung, malignant melanoma and pancreatic.