- August 25, 2017
- Taiho Pharmaceutical Co., Ltd.
Antitumor Agent Abraxane® I.V. Infusion 100 mg Approved for Additional Dosage and Administration for Gastric Cancer
Taiho Pharmaceutical Co., Ltd. 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 additional usage and dosage for weekly administration*1 for patients with gastric cancer from Japan’s Ministry of Health, Labour and Welfare.
Abraxane was approved in Japan to treat patients with breast cancer in July 2010, gastric cancer and non-small cell lung cancer in February 2013 and unresectable pancreatic cancer in December 2014. The additional usage and dosage in the gastric cancer indication was approved on the basis of the results*2 of a Phase III clinical study conducted in Japan (ABSOLUTE) in patients with a history of advanced gastric cancer. The previously approved regimen for gastric cancer patients called for administration every three weeks.*3
The ABSOLUTE study evaluated 741 unresectable, advanced, recurrent gastric cancer patients who were refractory to first line chemotherapy, including fluoropyrimidines, in order to demonstrate non-inferiority of Abraxane (administration in every three weeks or weekly) as compared to conventional paclitaxel (weekly administration). The results achieved the primary endpoint of non-inferiority in the overall survival (HR=0.97, 97.5% CI=0.76-1.23) for weekly administration of Abraxane (median: 11.1 months) as compared to conventional paclitaxel (median: 10.9 months). The non-inferiority for Abraxane in the once-every-three-weeks administration cohort (median: 10.3 months) was not confirmed (HR=1.06, 95% CI=0.87-1.31). The main adverse effects of Grade 3 or above observed during weekly administration of Abraxane were neutropenia (41%), leukopenia (22%), anemia (7%), loss of appetite (6%), lymphocytopenia (5%), febrile neutropenia (3%), and peripheral sensory neuropathy (2%).
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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 the development and marketing rights in Japan. Abraxane was initially approved in January 2005 by the U.S. FDA for the treatment of metastatic breast cancer. As of 1st August 2017, it has been approved in 71 countries worldwide, including the U.S. and Europe.
*1. Administration once per week is continued for a period of 3 weeks after which there is a treatment-free interval of 1 week, which constitutes a single course. This course may be repeated.
*2. Shitara K, et al. Lancet Gastroenterol Hepatol 2017; 2(4): 277-87.
*3. There is a treatment-free interval of at least 20 days after each administration, which constitutes a single course. This course may be repeated.
Product Information
| Product Name | Abraxane® I.V. Infusion 100 mg (paclitaxel injection [suspension with albumin]) |
|---|---|
| Indication | Breast cancer, gastric cancer, non-small cell lung cancer and unresectable pancreatic cancer |
| Dosage and Administration | (underlining indicates portions that were most recently approved) Method A should be used for breast cancer; either method A or method D should be used for gastric cancer; method B should be used for non-small cell lung cancer; and method C used 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 a 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 a 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 a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks followed by a one-week rest. The treatment cycle above is to be repeated. Dosage should be reduced based on the patient's condition. Method D: 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 a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks followed by a one-week rest. The treatment cycle above is to be repeated. Dosage should be reduced based on the patient's condition. |
Information in this news release was current as of the original release date.
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