美国食品及药物管理局FDA批准Abraxane还可用于减少常规乳腺癌化疗的副作用并促进其疗效。该药此前已获准用于治疗那些对常规化疗无反应的乳腺癌扩散患者或接受化疗半年后乳癌又重新复发了的患者。

    Abraxane是首个获准的蛋白质结合颗粒类药物，可为癌症患者提供一种全新的给药方式，即通过将乳腺癌化疗活性成分紫杉酚(Taxol)结合在微蛋白分子上而避免使用具有一定毒性的溶剂将其导入血液中，进而可大大减少后者可能引发的潜在有害副作用。涉及到460例晚期乳腺癌患者的一项临床研究已经证实，Abraxane可产生几乎为溶剂型紫杉酚两倍的反应率。有关专家专家们同时还指出，也正是由于这类蛋白质结合颗粒类药物不含有害的溶剂，因而可相应提高常规化疗剂量的50%而无需考虑其安全性。另外，这类药物也没有过敏测试之类的要求，可以在半小时内以常规静脉导管导入。

	Abraxane® is the first albumin-bound taxane particle of approximately 130 nanometers that takes advantage of albumin, a natural carrier of water-insoluble molecules (e.g., various nutrients, vitamins, and hormones) found in humans. Albumin is a protein that acts as the body's key transporter of nutrients and other water-insoluble molecules and selectively accumulates in tumor tissues.

FDA Approval
Abraxane® is an innovative therapy that has been approved by the United States Food and Drug Administration (FDA) for the treatment of patients with breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, with prior therapy including an anthracycline unless clinically contraindicated.

Safety
In the randomized metastatic breast cancer study, the most important adverse events included lower white and red blood cell counts, infections, tingling and numbness, nausea, vomiting, diarrhea, muscle and joint aches, and mouth sores. Other adverse reactions included weakness, visual disturbances, fluid retention, hair loss, and liver and kidney dysfunction. Low platelet counts, allergic reactions, cardiovascular reactions, and injection site reactions were uncommon.

WARNING ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

Please see Warnings, Precautions and Contraindications in the Product Information.