Gleevec (imatinib mesylate) tablets has receivedFDA approval to treat patients with fiverare, potentially life-threatening disorders,representing the first time that aregulatory authority has ever simultaneouslyapproved one targeted medicinefor so many disorders, according toNovartis, maker of Gleevec.
ROCKVILLE, Maryland--Gleevec(imatinib mesylate) tablets has receivedFDA approval to treat patients with fiverare, potentially life-threatening disorders,representing the first time that aregulatory authority has ever simultaneouslyapproved one targeted medicinefor so many disorders, according toNovartis, maker of Gleevec. The agentpreviously was approved for the treatmentof Philadelphia chromosome-positive(Ph+) chronic myeloid leukemia(CML) and gastrointestinal stromal tumors(GISTs).
Gleevec targets the activity of the tyrosinekinase Bcr-Abl and the receptortyrosine kinase Kit. Researchers havefound that Gleevec also inhibits othertyrosine kinases, including platelet-derivedgrowth factor receptor (PDGFR),which have been shown to be activatedin disease pathways that underlie a numberof rare hematologic diseases, as wellas some solid tumors.
The new approvals are for one solidtumor and four diseases of the blood:
Gleevec is indicated for adult patientswith unresectable, recurrent, and/ormetastatic DFSP at a dose of 800 mg/d.
Gleevec is indicated as a single agentfor the treatment of adult ALL patientsat a recommended dose of 600 mg/d.
Of a total population of 31 patientstreated for MDS/MPD with Gleevec, 14(45%) achieved a CHR and 12 (39%) an MCR. Of the 16 patients with a translocationassociated with PDGFR gene rearrangement,all had a hematologic response(13 CHR), and 12 had an MCR.Relevant target: PDGFR.Gleevec is indicated for adults withMDS/MPD associated with PDGFR generearrangements at a dose of 400 mg/d.
Gleevec is indicated for HES/CEL at adose of 400 mg/d. For HES/CEL patientswith demonstrated FIP1L1-PDGFRa fusionkinase, a starting dose of 100 mg/d isrecommended.
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