The Medical Letter TML n. 6/2014
Nr. 06 del 15/03/2014
TML n. 6/2014 – IN BREVE: Ponatinib ritorna in commercio negli Stati Uniti
La FDA ha revocato la sospensione della commercializzazione e della vendita del ponatinib (Iclusig-Ariad; approvato in Europa nel luglio 2013 e non disponibile in commercio in Italia) per il trattamento della leucemia (1); il farmaco, ritirato dal commercio nell’ottobre 2013, è stato immesso nuovamente sul mercato statunitense con indicazioni più ristrette e con avvertenze circa la sicurezza (2). Il ponatinib era stato ritirato a causa di un’incidenza elevata di eventi trombotici, in alcuni casi fatali. Le nuove indicazioni restringono l’impiego del farmaco ai pazienti T315l positivi e a quelli “per i quali non sono indicati altri inibitori delle tirosin-chinasi”, a causa di una probabile resistenza o intolleranza.
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