EMA approves ruxolitinib for the treatment of primary myelofibrosis and myelofibrosis secondary to polycythemia vera or essential thrombocythemia
Ruxolitinib is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients
- Date : 25 Apr 2012
- Topic : Cancer prevention
On 19 April 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product ruxolitinib (Jakavi, 5, 15, 20mg, tablet) intended for the treatment of chronic idiopathic myelofibrosis and treatment of myelofibrosis secondary to polycythemia vera or essential thrombocythemia. Ruxolitinib was designated as an orphan medicinal product on 7 November 2008 and 3 April 2009. The applicant for this medicinal product is Novartis Europharm Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
Antineoplastic activity of ruxolitinib linked to selective inhibition of Janus Associated Kinases
The active substance of Jakavi is ruxolitinib, a protein kinase inhibitor, ATC code: L01XE18, the antineoplastic activity of which is linked to the selective inhibition of the Janus Associated Kinases (JAKs) involved in the signalling mediation of a number of cytokines and growth factors that are important for hematopoiesis and immune function.
The benefits with ruxolitinib are its ability to reduce the size of the spleen by at least 35% and to treat other symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythemia vera myelofibrosis or post essential thrombocythemia myelofibrosis. The most common side effects are thrombocytopenia, anaemia and bleeding.
A pharmacovigilance plan for ruxolitinib will be implemented as part of the marketing authorisation.
The approved indication is: "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 polycythemia vera myelofibrosis or post essential thrombocythemia myelofibrosis.” It is proposed that ruxolitinib be prescribed by physicians experienced in the administration of anti-cancer agents.
Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for ruxolitinib and therefore recommends the granting of the marketing authorisation.
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