1 INDICATIONS AND USAGE
Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of:
Newly diagnosed adult and pediatric
patients with
Philadelphia
chromosome positive
chronic myeloid leukemia
(Ph+ CML) in
chronic phase
(1.1)
Patients with Philadelphia
chromosome positive
chronic myeloid leukemia (Ph+ CML) in
blast crisis (BC), accelerated phase (AP),
or in chronic phase (CP)
after failure of interferon-alpha therapy (1.2)
Adult patients
with relapsed or
refractory Philadelphia
chromosome
positive
acute lymphoblastic leukemia (Ph+ ALL) (1.3)
Pediatric patients
with newly diagnosed Philadelphia chromosome positive acute lymphoblastic
leukemia (Ph+ ALL) in combination with chemotherapy (1.4)
Adult patients
with myelodysplastic/myeloproliferative
diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor
receptor) gene re-arrangements
as determined with
an FDA-approved
test (1.5)
Adult patients
with aggressive
systemic mastocytosis (ASM)
without the
D816V c-Kit
mutation
as determined with an FDA-approved test or
with c-Kit mutational
status unknown (1.6)
Adult patients
with hypereosinophilic
syndrome (HES)
and/or chronic eosinophilic leukemia (CEL) who
have the
FIP1L1-PDGFRfusion kinase (mutational
analysis or
FISH demonstration of CHIC2 allele deletion)
and for
patients with
HES and/or CEL who are
FIP1L1-PDGFRfusion kinase negative or unknown (1.7)
Adult patients
with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans
(DFSP)
(1.8)
1.1 Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML)
Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
1.2 Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon-alpha (IFN) Therapy
Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
1.3 Adult patients with Ph+ Acute Lymphoblastic Leukemia (ALL)
Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
1.4 Pediatric patients with Ph+ Acute Lymphoblastic Leukemia (ALL)
Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
1.5 Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)
Adult patients with myelodysplastic/myeloproliferative diseases associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test [see Dosage and Administration (2.6)].
1.6 Aggressive Systemic Mastocytosis (ASM)
Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation as determined with an FDA- approved test [see Dosage and Administration (2.7)
] or with c-Kit mutational status unknown.
1.7 Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)
Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR fusion kinase negative or unknown.
1.8 Dermatofibrosarcoma Protuberans (DFSP)
Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.