Myelofibrosis (MF): Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Polycythaemia vera (PV): Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea. Graft versus host disease (GvHD): Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies.
SCEMBLIX is indicated for the treatment of adult patients with: ·Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). • Ph+ CML in CP with the T315I mutation
Kymriah is indicated for the treatment of: · Paediatric and young adult patients up to and including 25 years of age with CD19+ B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse. · Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Limitation of Use: Kymriah is not indicated for treatment of patients with primary or secondary central nervous system lymphoma. · Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Revolade is indicated for the treatment of patients aged 6 years and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Revolade is indicated for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Revolade is indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and paediatric patients 6 years and older with severe aplastic anaemia. Revolade is indicated for the treatment of adult patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy.
Acute myeloid leukaemia (AML) Rydapt is indicated in combination with standard induction and consolidation chemotherapy followed by single-agent maintenance therapy for adults with newly diagnosed acute myeloid leukaemia (AML) who have an FLT3 mutation. Advanced systemic mastocytosis (advanced SM) Rydapt is indicated for the treatment of adult patients with advanced systemic mastocytosis (advanced SM).
Tasigna 150mg and 200mg are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic Myelogenous leukaemia (CML) in the chronic phase. Tasigna 200mg only is indicated also for the treatment of Philadelphia chromosome positive chronic myeloid leukaemia (Ph+CML) in chronic phase or accelerated phase in patients resistant to or experiencing significant toxicity during treatment with imatinib.
Glivec® is indicated for the • Treatment of adult patients and children 3 years of age and above with Ph+ chronic myeloid leukaemia (Ph+ -CML) in chronic phase, accelerated phase or blast crisis. • Treatment of adult patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). • Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST. • Treatment of adult 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 unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. • Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements. • Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1- PDGFRα fusion kinase negative. • Treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-kit mutation