Reports from the Field: New leukemia drug approved
Reports from the Field
New leukemia drug approved
Trisenox (arsenic trioxide) injection, manufactured by Cell Therapeutics in Seattle, recently received approval from the Food and Drug Administration to treat patients with a severe form of leukemia whose disease has recurred or who have failed to respond to standard therapy.
A pivotal trial involving 40 patients with relapsed/refractory acute promyelocyctic leukemia (APL) unresponsive to standard therapies was conducted at nine institutions. Of those 40 patients treated with Trisenox, 70% achieved a complete remission, with the majority achieving molecular eradication of the genetic abnormality associated with APL. Complete remission was achieved on average within two months after initiation of Trisenox.
"We are impressed at both the high rate of complete remission and the relapse-free survival in this high-risk population of APL patients whose previous treatment failed to eradicate their disease," says Steven Soignet, MD, investigator in the Developmental Chemotherapy Service at Memorial Sloan-Kettering Cancer Center in New York City.
Trisenox is administered intravenously in two phases. Induction therapy consisting of daily injections of 0.15 mg/kg until the bone marrow is cleared of leukemic cells, for up to a maximum of 60 days. This is followed by consolidation therapy using the same dose for 25 days beginning three weeks after bone marrow remission is evident.
For information on Trisenox availability, call toll-free (888) 305-2289, or visit the Cell Therapeutics Web site at www.cticseattle.com.
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