Abstract
Abstract Background Combination therapy is a hallmark of cancer treatment. Approved combination therapies of anti-cancer drugs are classified into the following groups; broader than (Broad), the same as (Same), or a part of (Narrow) the series of combination regimen in clinical data packages submitted to Pharmaceuticals and Medical Devices Agency. Some anti-cancer drugs have restrictions in approved combination therapies although they have sufficient clinical findings except for the clinical data packages. In this context, the main objective is to investigate the relationships between approved combination therapies and clinical data packages, clarifying the drug profiles and target indications for each label description. This study can provide important information about approved combination therapy, which lead to secure and consistent access to effective anti-cancer drug combination therapy for cancer patients in Japan. Methods All approved indications which have been approved as Cancer since April 2006 to March 2017 were in scope. Number of approval records for combination therapy, difference in the combination regimen in clinical data package and condition of approved indication in label description, and number of combination therapy regimens in clinical data package and condition of approved indication were investigated. Results Among the eligible 97 approvals, 26 were approval for combination therapy. Among the 26 combination approvals, 9 consisting of 4 drugs were approved as Broad and out of 9, 7 were line extensions. Broad had average 2 combination regimens in clinical data packages while Same average 1 and Narrow average 4. Conclusions If the drugs whose efficacy has been established in several clinical trials and the regimen used in combination therapy in each clinical trial is different, Broad will be applied. There was no relationship between the number of combination therapy regimens in clinical data package and condition of approved indication.
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