| Avtor/Urednik | Tibau Martorell, Ariadna; Díez-González, Laura; Navarro, Beatriz; Galán-Moya, Eva M.; Templeton, Arnoud J.; Šeruga, Boštjan; Pandiella, Atanasio; Amir, Eitan; Ocaña, Alberto | |
| Naslov | Impact of availability of companion diagnostics on the clinical development of anticancer drugs | |
| Tip | članek | |
| Vol. in št. | Letnik 21, št. 3 | |
| Leto izdaje | 2017 | |
| Obseg | str. 337-343 | |
| ISSN | 1177-1062 - Molecular diagnosis & therapy | |
| Jezik | eng | |
| Abstrakt | Companion diagnostics permit the selection of patients likely to respond to targeted anticancer drugs; however, it is unclear if the drug development process differs between drugs developed with or without companion diagnostics. Identification of differences in study design could help future clinical development. PATIENTS AND METHODS: Anticancer drugs approved for use in solid tumors between 28 September 2000 and 4 January 2014 were identified using a search of the US FDA website. Phase III trials supporting registration were extracted from the drug label. Each published study was reviewed to obtain information about the phase I and II trials used for the development of the respective drug. RESULTS: We identified 35 drugs and 59 phase III randomized trials supporting regulatory approval. Fifty-three phase I trials and 47 phase II trials were cited in the studies and were used to support the design of these phase III trials. The approval of drugs using a companion diagnostic has increased over time (p for trend 0.01). Expansion cohorts were more frequently observed with drugs developed with a companion diagnostic (62 vs. 20%; p = 0.005). No differences between drugs developed with or without a companion diagnostic were observed for the design of phase I and II studies. CONCLUSIONS: The approval of drugs developed with a companion diagnostic has increased over time. The availability of a companion diagnostic was associated with more frequent use of phase I expansion cohorts comprising patients selected by the companion diagnostic. | |
| Proste vsebinske oznake | protitumorska zdravila tarčna zdravila diagnostika bolniki anticancer drugs targeted drugs companion diagnostics patients |