EPARs human use - Glivec//Imatinib mesilate

FICHA FARMACOLÓGICA de Imatinib mesilate. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. MAYO 16, 2009.-

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EPARs for authorised medicinal products for human use - Glivec

Active Substance
Imatinib mesilate
International Nonproprietary Name or Common Name
Imatinib mesilate
Pharmaco-therapeutic Group
protein-tyrosine kinase inhibitor
ATC Code
L01XE01

Therapeutic Indication:
Glivec is indicated for the treatment of:

- adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.

- adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

- adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.

- adult patients with relapsed or refractory Ph+ ALL as monotherapy.

- adult patients with myelodysplastic/ myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

- adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.

The effect of Glivec on the outcome of bone marrow transplantation has not been determined.

Glivec is also indicated for the treatment of

- adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).

- adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.

In adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with GIST and DFSP. The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Date of issue of Marketing Authorisation valid throughout the European Union
7 November 2001

Orphan medicinal product designation date
14 February 2001 (CML indication)
20 November 2001 (GIST indication)