- February 21, 2013
- Taiho Pharmaceutical Co., Ltd.
Antitumor Agent "ABRAXANE® I.V. Infusion 100 mg" Approved for Additional Indications of Gastric Cancer and Non-small Cell Lung Cancer
Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Masayuki Kobayashi) announced today that an antitumor agent "ABRAXANE® I.V. Infusion 100 mg" [paclitaxel injection (Suspension with Albumin), launched on September 24, 2010] received approval by the MHLW for the additional indications of gastric cancer and non-small cell lung cancer.
ABRAXANE® was approved for breast cancer on January 2005 in the United States and on July 2010 in Japan. As of February 2013, it is approved in metastatic breast cancer among 42 countries including the United States and European countries. It is the first time ABRAXANE® has been approved for the indication of gastric cancer based on Japanese clinical data, and the second for non-small cell lung cancer following the United States from the result of global phase 3 study.
Taiho Pharmaceutical believes ABRAXANE® will make a major contribution to both patients and medical personnel and remains committed to providing pertinent information about this drug.
About ABRAXANE® I.V. Infusion 100 mg
ABRAXANE® is a human serum albumin-bound paclitaxel with on average 130 nm nanoparticles. It does not require pre-medication with steroids or antihistamines to prevent hypersensitivity reactions, and makes treatment more convenient from the short infusion time. ABRAXANE® is available in more than 40 countries including Europe and the United States by Celgene Corporation.
|Product Name||ABRAXANE® I.V. Infusion 100 mg|
|Generic name||Paclitaxel Injection (Suspension with Albumin)
|Indication and Usage||Breast cancer, Gastric cancer, Non-small cell lung cancer|
|Dosage and Administration||Method A should be used for breast cancer and gastric cancer, and method B for NSCLC.
Method A: In usual cases, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 260 mg/m2 (body surface area), and the medication is then to be ceased for at least 20 days. The administration is to be repeated. Dosage should be reduced based on patient's condition.
Method B: In usual cases, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 100 mg/m2 (body surface area), and the medication is then to be ceased for at least 6 days. The administration is to be repeated while weekly medication is continued over a 3-week course. Dosage should be reduced based on patient's condition.
|Package||ABRAXANE® I.V. Infusion 100 mg: 1 vial
Information in this news release was current as of the original release date.