Cell Therapeutics, Inc. (cti) TRISENOX (arsenic trioxide) injection was approved today by the U.S. FDA to treat patients with a severe form of leukaemia whose disease has recurred or who have failed to respond to standard therapy.
“For patients with APL whose disease has recurred following initial treatment, the use of salvage therapy is highly toxic and rarely curative,” said Carolyn Paradise, M.D., Vice President of Clinical Development at cti.
“Results of the clinical trials using TRISENOX demonstrated that a significant number of those patients who suffered multiple relapses were able to achieve a complete remission, or a disappearance of all visible leukaemia cells. The majority of patients who achieved complete remission were still alive and disease-free with a median follow-up time of 16 months. This new treatment represents a significant advance for patients with this disease.”
A pivotal trial involving 40 patients with relapsed/refractory APL unresponsive to standard therapies was conducted at nine institutions, including Memorial Sloan-Kettering Cancer Centre in New York City and other leading cancer centres across the United States.
Seventy percent of these patients 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,” said Steven Soignet, M.D., investigator of Developmental Chemotherapy Service at Memorial Sloan- Kettering Cancer Centre in New York City.