News Release


 

Antitumor Agent "Abraxane® I.V. Infusion 100 mg" Approved for Additional Indication of Unresectable Pancreatic Cancer (18/12/2014)

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced today that an antitumor agent "Abraxane® I.V. Infusion 100 mg" [paclitaxel injection (suspension with albumin), launched in Japan in September, 2010] received approval for the additional indication of unresectable pancreatic cancer by Japan's Ministry of Health, Labour and Welfare.

Abraxane® was approved in Japan for breast cancer in July 2010, and for gastric cancer and non-small cell lung cancer in February 2013. The new indication was based on the results of Phase I/II clinical study in unresectable, advanced or recurrent pancreatic cancer patients conducted in Japan and an international Phase III study (MPACT) conducted by Celgene Corporation, Taiho Pharmaceutical's business partner.

Taiho Pharmaceutical anticipates Abraxane® making further contribution to patients and healthcare professionals in Japan with the addition of the new indication.

About Abraxane®
Abraxane®,which is albumin-bound nanoparticles of paclitaxel that can be reconstituted with saline solution, has confirmed its safety and efficacy. It was developed by Abraxis BioScience, Inc. and is marketed worldwide by Celgene Corporation, the parent company of Abraxis BioScience. Taiho Pharmaceutical has development and marketing rights in Japan. Abraxane® was approved in January 2005 by the U.S. FDA for treatment of breast cancer, and as of December 2014, it has been approved in 51 countries worldwide including the U.S. and European countries.

About the MPACT study
The MPACT study is an international Phase III study conducted in 11 countries including the U.S. and European countries for patients with previously untreated metastatic pancreatic cancer. Eight hundred and sixty one patients were randomized to either Abraxane plus gemcitabine (Abraxane 125mg/m2 and gemcitabine 1000mg/m2 was administered on days 1, 8 and 15 repeated every 28 days) or gemcitabine (cycle 1: gemcitabine 1000mg/m2 was administered once a week for consecutive 7 weeks followed by 1 week rest, cycle 2 and after: gemcitabine 1000mg/m2 was administered on days 1, 8 and 15 repeated every 28 days). The result showed significant prolongation in the primary endpoint of overall survival in Abraxane plus gemcitabine arm compared to gemcitabine arm. The median overall survival was 8.5 months for Abraxane plus gemcitabine arm (95%CI:7.9 - 9.5) and 6.7 months for gemcitabine arm respectively, and the hazard ratio was 0.72 (p<0.001). The common grade 3/4 adverse events observed in Abraxane plus gemcitabine arm include neutropenia (38%), leukopenia (31%), fatigue (17%) and peripheral neuropathy (17%).

About Celgene Corporation
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit  www.celgene.com.
 

 

Product Information

 

Product Name
 
Abraxane® I.V. Infusion 100 mg [Paclitaxel Injection (suspension with albumin)]
 
Indication and Usage (underline indicates revision)
 
Breast cancer, gastric cancer, non-small cell lung cancer and unresectable pancreatic cancer
 
Dosage and Administration (underline indicates revision)
 
Method A should be used for breast cancer and gastric cancer, method B for non-small cell lung cancer and method C for unresectable pancreatic cancer.
 
 
  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), followed by treatment free interval for at least 20 days. The treatment cycle above is to be repeated. Dosage should be reduced based on the 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), followed by treatment free interval for at least 6 days.The administration is once a week for 3 consecutive weeks, repeating this cycle subsequently. Dosage should be reduced based on the patient's condition.
 
Method C: In usual cases, in combination with gemcitabine, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 125 mg/m2 (body surface area), followed by treatment free interval for at least 6 days. The administration is once a week for 3 consecutive weeks followed by one week rest. The treatment cycle above is to be repeated. Dosage should be reduced based on the patient's condition.
 
 
Package
Abraxane® I.V. Infusion 100 mg: 1 vial

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