Imatero Indications/Uses

IMATERO is indicated for the: Treatment of patients with newly diagnosed Philadelphia chromosome (Bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML), as well as for the treatment of patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy or in accelerated phase or blast crisis.
Treatment of adult and pediatric above 1 year of age patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Treatment of adult patients with systemic mastocytosis (SM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.
Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL).
Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
The effectiveness of IMATERO is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in SM, HES/CEL. Increased survival in controlled trials has been demonstrated only in newly diagnosed chronic phase CML.