Glivec effective as therapy for rare cancers

Swiss drug major Novartis says it has completed further regulatory filings requesting approval of its anticancer agent Glivec (imatinib) as a treatment for four rare cancers. The drug, which was first approved by the US Food and Drug Administration in 2001, is used to inhibit tyrosine kinase function in cancerous cells, particularly in Philadelphia-chromosome positive chronic myeloid leukemia and CD117-positive gastrointestinal stromal tumors (GIST).

Subsequent research has shown that the compound inhibits other tyrosine kinase-mediated pathways which form the basis of numerous cancers and hematologic diseases. Specifically, the firm is seeking Glivec's approval for use in the treatment of: dermatofibrosarcoma protuberans, a tumor found in the skin of the chest, abdomen or leg; the hematologic disease hypereosinophilic syndrome, which is characterized by the over-production of eosinophils by the bone marrow; systemic mastocytosis; and other Glivec-susceptible myeloproliferative disorders.

Novartis added that it had submitted marketing applications in Europe and the USA for DFSP in 2005 and for SM and HES earlier this year. The submissions were based on data from a series of company-sponsored clinical studies which demonstrated the efficacy and safety of Glivec in the treatment of this group of rare diseases.