GLIVEC

Glivec^®

Traditional approaches to cancer treatment, including chemotherapy and radiation, eliminate cancer cells, but at a great cost, as undesirable effects often occur to healthy cells. Continued research into life-threatening diseases has led to an understanding of the underlying causes of disease. Cancer treatment is now in the era of molecularly targeted therapy. Glivec is the paradigm for molecular targeting of disease and lies at the forefront of this change in cancer management.

Glivec (imatinib) has revolutionised the treatment and continued management of chronic myeloid leukaemia (CML) and gastrointestinal stromal tumour (GIST) through precise molecular targeting.

In clinical studies of chronic-phase CML patients treated for 5 years with Glivec, an estimated 98% had their blood counts stabilised, and 92% had a major cytogenetic response. Estimated 5-year survival rates of 89% have been reported for patients with newly diagnosed chronic phase CML receiving 400 mg of Glivec^{1, 2}.

Glivec is also approved for treatment of adult patients with KIT (CD117)-positive unresectable and/or metastatic malignant GIST. At 52-month follow-up, results of the pivotal phase 2 B2222 trial have demonstrated that 84% of patients with advanced GIST were able to achieve stable disease or better^{4, 5} (16% achieved stable disease, 67% achieved a partial response, and 1% achieved a complete response). The median overall survival with Glivec is 4.8 years.

The remarkable success achieved with Glivec as therapy for CML and metastatic and /or unresectable GIST has established Glivec as the standard of care for these malignancies^{4, 5}.

Glivec has been approved for the treatment of³: [Glivec SPC, 2008; p2a, p26a, p50a, p74a]

·         adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcrabl) positive (Ph+) 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 interferonalpha therapy, or in accelerated phase or blast crisis

·         adult patients with newly diagnosed Ph+ 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.

Glivec is also indicated for the treatment of:

·         adult patients with Kit (CD 117)-positive unresectable and/or metastatic malignant GIST

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

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

Find out about efficacy, dosage, and safety in Prescribing Glivec

Learn about the time line of Glivec development.