Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan
Background The utilization of biomarkers has become increasingly active to enhance efficiency of clinical development. This study evaluated the current situation and quantitative impact of co-development of companion diagnostics (CDx) on the oncology drug development in Japan. Methods Based on publi...
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Veröffentlicht in: | Therapeutic innovation & regulatory science 2022, Vol.56 (1), p.85-95 |
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creator | Tanaka, Akari Suzuki, Hirofumi Toyoshima, Satoshi Nagai, Naomi |
description | Background
The utilization of biomarkers has become increasingly active to enhance efficiency of clinical development. This study evaluated the current situation and quantitative impact of co-development of companion diagnostics (CDx) on the oncology drug development in Japan.
Methods
Based on publicly available information about the oncology drugs and CDx approved in Japan in 2010–2020, we evaluated the approval lag time between drugs and CDx, and the duration between the pivotal study start date and the new drug application submission date (the time to application). Influences of multiple factors including the use of CDx on the time to application were also analyzed.
Results
A diagnostic test was mostly used from an early development phase such as phase1/2 study, and the median approval lag has tended to decrease when approved CDx were used (− 507 vs. − 25 days for newly developed CDx). The shorter median times to application were observed in Drugs with CDx (1204 days) compared to Targeted therapies without CDx (1423 days) or Other drugs without CDx (1853 days), although both the cancer types and the implementation of multi-regional clinical trials have a larger impact on the time to application compared to the use of CDx.
Conclusions
The use of CDx from the early development phase and the global development strategy could have a positive contribution on the development period of oncology drugs, which will facilitate patients’ earlier access to the optimal treatment. |
doi_str_mv | 10.1007/s43441-021-00332-6 |
format | Article |
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The utilization of biomarkers has become increasingly active to enhance efficiency of clinical development. This study evaluated the current situation and quantitative impact of co-development of companion diagnostics (CDx) on the oncology drug development in Japan.
Methods
Based on publicly available information about the oncology drugs and CDx approved in Japan in 2010–2020, we evaluated the approval lag time between drugs and CDx, and the duration between the pivotal study start date and the new drug application submission date (the time to application). Influences of multiple factors including the use of CDx on the time to application were also analyzed.
Results
A diagnostic test was mostly used from an early development phase such as phase1/2 study, and the median approval lag has tended to decrease when approved CDx were used (− 507 vs. − 25 days for newly developed CDx). The shorter median times to application were observed in Drugs with CDx (1204 days) compared to Targeted therapies without CDx (1423 days) or Other drugs without CDx (1853 days), although both the cancer types and the implementation of multi-regional clinical trials have a larger impact on the time to application compared to the use of CDx.
Conclusions
The use of CDx from the early development phase and the global development strategy could have a positive contribution on the development period of oncology drugs, which will facilitate patients’ earlier access to the optimal treatment.</description><identifier>ISSN: 2168-4790</identifier><identifier>EISSN: 2168-4804</identifier><identifier>DOI: 10.1007/s43441-021-00332-6</identifier><identifier>PMID: 34406635</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Antineoplastic Agents - therapeutic use ; Biomarkers ; Clinical trials ; Drug Development ; Drug Safety and Pharmacovigilance ; Drugs ; Humans ; Japan ; Lag time ; Medicine ; Neoplasms - drug therapy ; Oncology ; Original Research ; Pharmacotherapy ; Pharmacy</subject><ispartof>Therapeutic innovation & regulatory science, 2022, Vol.56 (1), p.85-95</ispartof><rights>The Drug Information Association, Inc 2021</rights><rights>2021. The Drug Information Association, Inc.</rights><rights>The Drug Information Association, Inc 2021.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-6e2d1b1194a801504c30639128e1fa2068267a4a561bb7c6a41d64123a9f74f93</citedby><cites>FETCH-LOGICAL-c375t-6e2d1b1194a801504c30639128e1fa2068267a4a561bb7c6a41d64123a9f74f93</cites><orcidid>0000-0003-4674-6636</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s43441-021-00332-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s43441-021-00332-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34406635$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tanaka, Akari</creatorcontrib><creatorcontrib>Suzuki, Hirofumi</creatorcontrib><creatorcontrib>Toyoshima, Satoshi</creatorcontrib><creatorcontrib>Nagai, Naomi</creatorcontrib><title>Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan</title><title>Therapeutic innovation & regulatory science</title><addtitle>Ther Innov Regul Sci</addtitle><addtitle>Ther Innov Regul Sci</addtitle><description>Background
The utilization of biomarkers has become increasingly active to enhance efficiency of clinical development. This study evaluated the current situation and quantitative impact of co-development of companion diagnostics (CDx) on the oncology drug development in Japan.
Methods
Based on publicly available information about the oncology drugs and CDx approved in Japan in 2010–2020, we evaluated the approval lag time between drugs and CDx, and the duration between the pivotal study start date and the new drug application submission date (the time to application). Influences of multiple factors including the use of CDx on the time to application were also analyzed.
Results
A diagnostic test was mostly used from an early development phase such as phase1/2 study, and the median approval lag has tended to decrease when approved CDx were used (− 507 vs. − 25 days for newly developed CDx). The shorter median times to application were observed in Drugs with CDx (1204 days) compared to Targeted therapies without CDx (1423 days) or Other drugs without CDx (1853 days), although both the cancer types and the implementation of multi-regional clinical trials have a larger impact on the time to application compared to the use of CDx.
Conclusions
The use of CDx from the early development phase and the global development strategy could have a positive contribution on the development period of oncology drugs, which will facilitate patients’ earlier access to the optimal treatment.</description><subject>Antineoplastic Agents - therapeutic use</subject><subject>Biomarkers</subject><subject>Clinical trials</subject><subject>Drug Development</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Drugs</subject><subject>Humans</subject><subject>Japan</subject><subject>Lag time</subject><subject>Medicine</subject><subject>Neoplasms - drug therapy</subject><subject>Oncology</subject><subject>Original Research</subject><subject>Pharmacotherapy</subject><subject>Pharmacy</subject><issn>2168-4790</issn><issn>2168-4804</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kctqGzEYhUVoaEKSF-giCLrpZlrdRhplZ-xeMaSUdi1-z2jMhBlpKnkMfpE8b3_XzoUsIhAS0vnOETqEvOPsI2fMfMpKKsULJnAyKUWhT8i54LoqVMXUm4e9seyMXOV8x3DYqjSiekvOEGVay_Kc3M9jsfBb38dx8GFDY0tvQx37uN7RRZrWmUJo6DwOI4QuBrroYB1i3nR1vqGzAP0u-7ynZuOY4hZ6uoQjtMfpc--fPnWxybQL9Jev8aTfHTGPEbA3wqsfgFGX5LSFPvur43pB_nz5_Hv-rVjefv0-ny2LWppyU2gvGr7i3CqoGC-ZqiXT0nJRed6CYLoS2oCCUvPVytQaFG-04kKCbY1qrbwgHw6--Iq_k88bN3S59n0PwccpO1FqUXJbKYPS9y-kd3FK-AOo0hyzrDUSVeKgqlPMOfnWjakbIO0cZ25fnDsU57A49784pxG6PlpPq8E3j8hDTSiQB0HGq7D26Sn7Fdt_GnGibA</recordid><startdate>2022</startdate><enddate>2022</enddate><creator>Tanaka, Akari</creator><creator>Suzuki, Hirofumi</creator><creator>Toyoshima, Satoshi</creator><creator>Nagai, Naomi</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U7</scope><scope>C1K</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-4674-6636</orcidid></search><sort><creationdate>2022</creationdate><title>Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan</title><author>Tanaka, Akari ; Suzuki, Hirofumi ; Toyoshima, Satoshi ; Nagai, Naomi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-6e2d1b1194a801504c30639128e1fa2068267a4a561bb7c6a41d64123a9f74f93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Antineoplastic Agents - therapeutic use</topic><topic>Biomarkers</topic><topic>Clinical trials</topic><topic>Drug Development</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Drugs</topic><topic>Humans</topic><topic>Japan</topic><topic>Lag time</topic><topic>Medicine</topic><topic>Neoplasms - drug therapy</topic><topic>Oncology</topic><topic>Original Research</topic><topic>Pharmacotherapy</topic><topic>Pharmacy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tanaka, Akari</creatorcontrib><creatorcontrib>Suzuki, Hirofumi</creatorcontrib><creatorcontrib>Toyoshima, Satoshi</creatorcontrib><creatorcontrib>Nagai, Naomi</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Therapeutic innovation & regulatory science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tanaka, Akari</au><au>Suzuki, Hirofumi</au><au>Toyoshima, Satoshi</au><au>Nagai, Naomi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan</atitle><jtitle>Therapeutic innovation & regulatory science</jtitle><stitle>Ther Innov Regul Sci</stitle><addtitle>Ther Innov Regul Sci</addtitle><date>2022</date><risdate>2022</risdate><volume>56</volume><issue>1</issue><spage>85</spage><epage>95</epage><pages>85-95</pages><issn>2168-4790</issn><eissn>2168-4804</eissn><abstract>Background
The utilization of biomarkers has become increasingly active to enhance efficiency of clinical development. This study evaluated the current situation and quantitative impact of co-development of companion diagnostics (CDx) on the oncology drug development in Japan.
Methods
Based on publicly available information about the oncology drugs and CDx approved in Japan in 2010–2020, we evaluated the approval lag time between drugs and CDx, and the duration between the pivotal study start date and the new drug application submission date (the time to application). Influences of multiple factors including the use of CDx on the time to application were also analyzed.
Results
A diagnostic test was mostly used from an early development phase such as phase1/2 study, and the median approval lag has tended to decrease when approved CDx were used (− 507 vs. − 25 days for newly developed CDx). The shorter median times to application were observed in Drugs with CDx (1204 days) compared to Targeted therapies without CDx (1423 days) or Other drugs without CDx (1853 days), although both the cancer types and the implementation of multi-regional clinical trials have a larger impact on the time to application compared to the use of CDx.
Conclusions
The use of CDx from the early development phase and the global development strategy could have a positive contribution on the development period of oncology drugs, which will facilitate patients’ earlier access to the optimal treatment.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>34406635</pmid><doi>10.1007/s43441-021-00332-6</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-4674-6636</orcidid></addata></record> |
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subjects | Antineoplastic Agents - therapeutic use Biomarkers Clinical trials Drug Development Drug Safety and Pharmacovigilance Drugs Humans Japan Lag time Medicine Neoplasms - drug therapy Oncology Original Research Pharmacotherapy Pharmacy |
title | Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan |
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