Tibisan Indications/Uses

TIBISAN is indicated for the: Treatment of patients with newly diagnosed Philadelphia chromosome (BCR-ABL) positive (Ph+) chronic myeloid leukemia (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 leukemia (Ph+ ALL) integrated with chemotherapy.
Treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Treatment of adult patients with myelodysplastic/myeloproliferative disease (MDS/MDP) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements.
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 TIBISAN is based on overall hematological and cytogenetic response rates and progression-free survival in CML, on hematological and cytogenetic response rates in PH+ALL, MDS/MDP, on hematological response rates in SM, HES/CEL, and on objective response rates in DFSP.