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Dave Levitan

Articles by Dave Levitan

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.

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.

Evidence continues to mount that discontinuing imatinib treatment for chronic myeloid leukemia (CML) in the chronic phase is safe. A new phase II Dutch and Belgian study showed only about two-thirds of patients relapsed after discontinuing treatment with imatinib and cytarabine, and all patients remained sensitive to imatinib after relapse.

A randomized phase III trial of adjuvant gefitinib in patients with completely resected non–small-cell lung cancer (NSCLC) was closed early, but available results suggest that the drug is unlikely to benefit this group of patients.

Maintenance therapy with rituximab showed some improvement over observation, though it did not reach significance, among older patients with advanced follicular lymphoma who responded to a brief chemoimmunotherapy induction regimen followed by rituximab consolidation therapy.