- February 13, 2013
- Taiho Pharmaceutical Co., Ltd.
Condition for Approval (All-Patient Enrollment)of ABRAXANE® I.V. Infusion 100mg Antineoplastic Removed
Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Masayuki Kobayashi) announced that the Second Committee on Drugs of the Ministry of Health, Labour and Welfare's Pharmaceutical Affairs and Food Sanitation Council has removed the condition for approval*1 it had imposed on ABRAXANE® 100mg I.V. antineoplastic (albumin-bound paclitaxel for injectable suspension).
This action was due to the release of the final report on a treatment outcome study (all-patient surveillance, 934 subjects enrolled between September 2010 and February 2011).
*1. Condition for approval: Due to the fact that there are severe limitations on cases used in clinical trials in Japan, after a drug is placed on the market, a treatment outcome study on all subjects (patients) is carried out before the data on a fixed number of subjects is compiled. This allows an understanding of the descriptive data of the patients using the drug, allows data on the safety and efficacy of the drug to be obtained quickly, and allows necessary measures regarding the proper use of the drug to be adopted.
The treatment outcome study (all-patient surveillance) condition for approval was imposed when ABRAXANE® was approved as an effective treatment for breast cancer in July 2010.
The condition for approval imposed upon ABRAXANE® was removed because the safety and efficacy demonstrated for the total number of patients participating in the study (934) was judged to satisfy the treatment outcome study condition for approval, and because the required measures for proper use were adopted, making further study unnecessary. In addition, though medical personnel were requested to carry out all-patient enrollment*2 after the all-patient surveillance was registered, this was discontinued due to the lifting of the condition for approval.
*2. See the Q&A (Official Communication of the Safety Division, Evaluation and Licensing Division of the Ministry of Health, Labour and Welfare's Pharmaceutical and Food Safety Bureau) regarding all-patient surveillance and post-marketing surveillance of prescription drugs.
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 and making sure it is used properly.
Summary of Results
Between September 24, 2010, when the drug was launched, and February 14, 2011, 943 subjects were enrolled to begin treatment using ABRAXANE®. The drug was evaluated to be safe in 934 of these subjects, excluding overlaps and other conditions. Side effects were presented in 867 subjects, indicating that the incidence rate for side effects was 92.8%. The incidence rate for severe side effects was 16.9%. Side effects peculiar to this drug and their incidence rates are as follows: leukocytopenia 64.8%, neutropenia 56.2%, peripheral sensory neuropathy 23.7%, and hypoesthesia 39.4%. Severe side effects and their incidence rates are as follows: leukocytopenia (10.0%), neutropenia (9.1%), hypoesthesia (2.1%), and peripheral sensory neuropathy (1.7%), among others. Most of these side effects were included among those indicated in the drug's package insert and are consistent with the side effects reported for other paclitaxel drugs. However, the study showed that the side effect incidence rates for subjects with grade 3 and higher hepatic dysfunction was higher than that for subjects with normal liver function. These subjects were sampled for a factor analysis.
Please refer to the Taiho Pharmaceutical website, http://www.taiho.co.jp/medical/abraxane/ (Japanese language only) for information regarding the results of the treatment outcome study (all-patient surveillance).
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® was developed by Abraxis BioScience LLC. and is sold in Europe and the United States by Celgene Corporation, its parent company.
Information in this news release was current as of the original release date.