Does Industry‐Conducted All‐Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan?

Suzuki, Atsuko; Sato, Hitoshi; Sasaki, Yasutsuna

doi:10.1111/cts.12644

Cited by 4 publications

(3 citation statements)

References 26 publications

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“…However, the survey period was 6 years, and there was no indication of how the PACS results were reflected in the safety measures. In addition, with regard to how PACS results were reflected in safety measures, Suzuki et al investigated whether the PACS results of anticancer drugs were reflected in their package inserts, and the results were found to be partially reflected, with most results being reflected in revisions to the package inserts due to serious adverse events [ 9 ]. However, this survey limits the target drugs to anticancer drugs, and there is no description related to the PACS results of other drugs that were approved in Japan.…”

Section: Discussionmentioning

confidence: 99%

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Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999–2019

et al. 2022

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Background Postmarketing all-case surveillance (PACS) is a safety monitoring activity predominantly conducted for drugs with few domestic clinical trials, orphan drugs, or anticancer drugs that potentially cause serious adverse events. Aim This study comprehensively analyzed drugs in Japan requiring PACS as an approval condition and those implementing PACS-results-based safety measures. Method We included drugs approved in Japan between 1999 and 2019. Results During the 20-year survey, 1871 drugs were approved in Japan, including 277 (14.8%) requiring PACS as an approval prerequisite. The drug number requiring PACS for approval and its ratio to the total approved-drug number is increasing annually. In 2018, the number and percentage of PACS-requiring drugs reached a 37-drug maximum (32.5%). Additionally, among the 277 PACS-requiring drugs, upon examining the results of 87 drugs for which reexamination results had already been obtained, all 87 drugs (31.4%) were found to be in Category 1 which means there is no need to revise drug-approval conditions, indicating that their usefulness is consistent with approval. Furthermore, measures such as revising the package insert and providing information to medical institutions were adopted for 53 drugs, 14 of which had PACS-results-based safety measures. Conclusion PACS implementation for drug approval will potentially continue increasing. Normally, PACS is not conducted overseas, as it is a safety-monitoring activity exclusive to Japan, and the burden on institutions, such as medical sites and pharmaceutical companies, is heavy. Thus, ensuring a balance between the obtained effect and this burden is imperative.

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Section: Discussionmentioning

confidence: 99%

“…In 1995, irinotecan was the first to require post-marketing all-case surveillance (PACS) as a condition for approval [ 9 ]. Thereafter, PACS became widespread from around 1999 as a post-marketing safety measure [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999–2019

et al. 2022

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“…To assess the safety and effectiveness of temsirolimus in real-world clinical settings in Japan, a prospective, observational, post-marketing surveillance (PMS) study was conducted as part of a mandatory, post-approval regulatory requirement. An all-case surveillance methodology ( 16 ) was adopted to accumulate data on the real-world safety and effectiveness of temsirolimus as early as possible and to ensure that necessary measures are taken for the proper use of temsirolimus in patients with RCC in Japan ( ClinicalTrials.gov identifier NCT01210482 and NCT01420601).…”

Section: Introductionmentioning

confidence: 99%

Real-world use of temsirolimus in Japanese patients with unresectable or metastatic renal cell carcinoma: recent consideration based on the results of a post-marketing, all-case surveillance study

Sugiyama

Sato

Shibasaki

et al. 2020

Japanese Journal of Clinical Oncology

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Objective A prospective, observational, post-marketing surveillance was conducted to assess the safety and effectiveness of temsirolimus in patients with renal cell carcinoma in Japan. Methods Patients prescribed temsirolimus for advanced renal cell carcinoma were registered and received temsirolimus (25 mg weekly, intravenous infusion for 30–60 minutes) in routine clinical settings (observation period: 96 weeks). Results Among 1001 patients included in the safety analysis data set (median age, 65.0 years; men, 74.8%; Eastern Cooperative Oncology Group performance status 0 or 1, 69.6%), 778 (77.7%) reported adverse drug reactions. The most common (≥10%) all-grade adverse drug reactions were stomatitis (26.7%), interstitial lung disease (17.3%) and platelet count decreased (11.1%). The incidence rate of grade ≥3 interstitial lung disease was 4.5%. The onset of interstitial lung disease was more frequent after 4–8 weeks of treatment or in patients with lower Eastern Cooperative Oncology Group performance status (21.6% for score 0 vs 8.3% for score 4, P < 0.001). Among 654 patients in the effectiveness analysis data set, the response and clinical benefit rates were 6.7% (95% confidence interval 4.9–8.9) and 53.2% (95% confidence interval 49.3–57.1), respectively. The median progression-free survival was 18.3 weeks (95% confidence interval 16.9–21.1). Conclusions The safety and effectiveness profile of temsirolimus observed in this study was similar to that observed in the multinational phase 3 study. The results are generalizable to the real-world scenario at the time of this research, and safety and effectiveness of temsirolimus as a subsequent anticancer therapy for renal cell carcinoma warrants further investigation. (ClinicalTrials.gov identifier NCT01210482, NCT01420601).

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Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis

Ito

Narukawa

2022

Ther Innov Regul Sci

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Does Industry‐Conducted All‐Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan?

Cited by 4 publications

References 26 publications

Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999–2019

Postmarketing all-case surveillance trends and contribution to safety measures of drugs approved in Japan: a cross-sectional survey in 1999–2019

Real-world use of temsirolimus in Japanese patients with unresectable or metastatic renal cell carcinoma: recent consideration based on the results of a post-marketing, all-case surveillance study

Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis

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