The FDA granted Gleevec a priority review and approved the drug after only a 2 ½-month review time, making this the fastest approval to market any cancer treatment.
Clinical Data
The FDA approval of Gleevec was based on data from three phase II open-label, single-arm studies that showed a major cytogenetic response (complete response = 0% Philadelphia chromosome-positive [Ph+] metaphases; partial response = up to 35% Ph+ metaphases) in patients with advanced stages of CML. Patients with chronic-phase CML after failure with interferon therapy achieved an 88% hematologic response and 49% overall major cytogenetic response—both primary end points of the study.
Toxicity
The majority of Gleevec-treated patients experienced adverse events at some time. Most events were mild to moderate grade, but the drug was discontinued for adverse events in 1% of patients in chronic phase, 2% in accelerated phase, and 5% in blast crisis. In clinical trials in the three phases of CML studied, adverse events, regardless of relationship to study drug, include nausea (55% to 68%), fluid retention (52% to 68%), muscle cramps (25% to 46%), diarrhea (33% to 49%), vomiting (28% to 54%), hemorrhage (13% to 48%), musculoskeletal pain (27% to 39%), skin rash (32% to 39%), headache, (24% to 28%) and fatigue (24% to 33%). Edema was most frequently periorbital or in lower limbs and was managed with diuretics, other supportive measures, or by reducing the dose of Gleevec. The frequency of severe edema was 1% to 5%. More serious side effects include elevated liver enzymes (1.1% to 3.5%), severe superficial edema (1% to 5%), and hemorrhages (0.4% to 16%).
Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec. Treatment with Gleevec is often associated with neutropenia and/or thrombocytopenia.
Patient Assistance
Novartis has put a comprehensive patient assistance program in place, which insures that uninsured, indigent patients are not denied therapy for economic reasons. A reimbursement hotline is in place and can be reached at 1-877-GLEEVEC.
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Oncology Vol 31 No 10
Oct 15, 2017 Vol 31 No 10
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