Approving molecularly targeted drugs: different approval processes for cytotoxic agents
| Autor: | Yuriko Ito Sasahara, Akira Fukao, Takashi Yoshioka, Hiroto Narimatsu |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Drug
medicine.medical_specialty Time Factors media_common.quotation_subject Alternative medicine Antineoplastic Agents Pharmacology 03 medical and health sciences 0302 clinical medicine Japan Neoplasms medicine Humans Regulatory science Molecular Targeted Therapy 030212 general & internal medicine Risks and benefits Formulary Intensive care medicine Drug Approval media_common Pharmacopoeias as Topic Clinical Trials as Topic Cytotoxins business.industry Data assessment Hematology General Medicine Clinical trial Survival benefit Oncology 030220 oncology & carcinogenesis Surgery business |
| Zdroj: | International Journal of Clinical Oncology. 21:1004-1013 |
| ISSN: | 1437-7772 1341-9625 |
| DOI: | 10.1007/s10147-016-0980-2 |
| Popis: | Recently, the approval of some molecularly targeted drugs has been questioned, due to differing opinions on their risks and benefits. The approval process remains a challenge in regulatory science. We analyzed the molecularly targeted drugs listed in the 2013 Medical Formulary. For the 21 identified drugs, 32 published Pharmaceuticals and Medical Devices Agency (PMDA) reports were open to the public. Data regarding clinical trials were extracted from these reports and assessed in order to clarify the characteristic examinations required for the approval of molecularly targeted drugs. There was no correlation between the application year and the time between application and approval (p = 0.139). The median number of clinical trials in these reports was 5 (range 1–22). Phase III studies were not included in the assessment materials for 11 reports. A survival benefit was demonstrated for six of the 32 drugs. The PMDA issued approval terms, including all-case surveillance and additional clinical trials, for 24 of these 32 drugs. Molecularly targeted drugs were approved by the PMDA using a flexible process based on drug safety and efficacy. Doctors and patients who are administering or receiving these drugs should be fully informed about the lack of Japanese data assessment during these approval processes. |
| Databáze: | OpenAIRE |
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