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Hematologic Oncology

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Ponatinib showed significant antileukemic activity in patients with CML and ALL, according to a phase II study that included a wide range of disease stages and mutation status; patients in the trial had a relatively high rate of adverse thrombotic events, an issue which has led to recent regulatory controversy surrounding the drug.

Following recent trial data showing an increased risk of dangerous blood clots with ponatinib, which led the FDA to request that the manufacturer stop marketing the drug, the FDA’s European counterpart has adjusted its recommendations for ponatinib but has not changed its “positive opinion” that led to the approval.

This article reviews the etiology and incidence of renal adverse events in patients with multiple myeloma, the renal safety profile of single-agent carfilzomib from four phase II studies in patients with relapsed and/or refractory multiple myeloma, and the management of patients with multiple myeloma who receive carfilzomib and are at risk for renal complications.

This article presents an overview of the cardiac and pulmonary safety profile of single-agent carfilzomib therapy in patients with relapsed and/or refractory multiple myeloma from an analysis of four phase II clinical studies, and provides practical recommendations for the management of patients at risk for cardiac events and pulmonary complication.

In the wake of reports that the drug ponatinib (Iclusig) can significantly increase risk of dangerous cardiovascular events, the FDA has asked the manufacturer to suspend sales and marketing of the drug in the United States.