Approved
Targeted Therapy

Ruxolitinib (JAKAVI®)

Primo-indication

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 (see section 5.1).

Intervention Type

Pharmaceutical

Solid/Hematological

Hematological

Cancer Type

Myelofibrosis

Therapy Types

Targeted Therapy

Regulatory

FDA

N/A

Regulatory Pathway: n/a

EMA

23.08.2012

Regulatory Pathway: standard approval

Availability in other countries

N/A

Focus Area

Cancer

ASMR

III

Medical Need

Partially met

SMR

IMPORTANT

Orphan Status

Yes

Other resources