yuyun 2009-11-30 11:28
Paclitaxel獲得以孤兒藥方式核准用於難以治療的癌症
作者：Yael Waknine
出處：WebMD醫學新聞
November 10, 2009 — 美國食品藥物管理局(FDA)以孤兒藥方式核准paclitaxel-白蛋白連結顆粒注射型懸液劑(商品名Abraxane；Abraxis BioScience, Inc公司)，用於治療胰臟癌和第2B期-第4期黑色素瘤。
胰臟癌和轉移黑色素瘤特別難治療。估計美國今年有42,000人診斷為胰臟癌，此病症後期往往會轉移，每年有超過35,000人死於此症。黑色素瘤是皮膚癌的首要致死原因，每年在美國影響超過68,000人，末期疾病的5年存活率目前只有25%。
根據該公司的新聞稿指出，目前正持續招募患者，以進行第3期臨床試驗，未來將評估將paclitaxel加入gemcitabine治療末期轉移胰臟癌的效果。另一篇第3期研究，將比較paclitaxel和dacarbazine，正積極招募未曾化療過的第4期黑色素瘤病患。
Paclitaxel-白蛋白連結顆粒注射型懸液劑之前獲得FDA核准，用於併用治療失敗之乳癌的轉移疾病或輔助化療6個月內復發者；除非有臨床禁忌，之前的治療應包括一種anthracycline。
Paclitaxel Granted Orphan Drug Status for Hard-to-Treat Cancers
By Yael Waknine
Medscape Medical News
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-naive 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.