Paclitaxel Granted Orphan Drug Status for Hard-to-Treat Cancers

Yael Waknine

November 10, 2009

November 10, 2009 — The US Food and Drug Administration (FDA) has granted orphan drug designation for paclitaxel albumin-bound particles for injectable suspension (Abraxane; Abraxis BioScience, Inc) in the treatment of pancreatic cancer and stage IIB to IV melanoma.

Pancreatic cancer and metastatic melanoma can be particularly difficult to treat. An estimated 42,000 patients in the United States will be diagnosed with pancreatic cancer this year, often after the disease has metastasized; more than 35,000 die from the condition annually. Melanoma is the leading cause of skin cancer death and affects more than 68,000 people in the United States each year; the 5-year survival rate for advanced disease is currently only 25%.

According to a company news release, enrollment is ongoing for a phase 3 clinical study that will evaluate the benefits of adding paclitaxel to gemcitabine therapy for advanced metastatic pancreatic cancer. Another phase 3 study, comparing paclitaxel with dacarbazine, is actively enrolling chemotherapy-naïve stage IV melanoma patients.

Paclitaxel albumin-bound particles for injectable suspension was previously approved by the FDA for the treatment of breast cancer after the failure of combination therapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; previous therapy should have included an anthracycline unless clinically contraindicated.


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