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FDA grants priority review to Trisenox for first-line acute promyelocytic leukemia
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The FDA granted priority review to arsenic trioxide injection for use in combination with all-trans retinoic acid for induction of remission and consolidation in certain patients with acute promyelocytic leukemia.
The priority review designation applies to use of the combination for patients with newly diagnosed low- or intermediate-risk disease that includes t(15;17) translocation or PML/RAR-alpha gene expression.
The FDA previously approved arsenic trioxide injection (Trisenox, Teva Pharmaceutical Industries Ltd.) for induction of remission and consolidation in patients with acute promyelocytic leukemia with t(15;17) translocation or PML/RAR-alpha gene expression who are refractory to or relapsed after retinoid and anthracycline chemotherapy.
“With over 15 years of clinical experience, Trisenox is an important treatment option for acute promyelocytic leukemia patients,” Paul Rittman, senior vice president and general manager of Teva Oncology, said in a company-issued press release. “Teva is committed to providing solutions that advance cancer care. We are very pleased that the FDA has accepted the supplemental new drug application for priority review.”
The FDA is expected to make a decision on the supplemental application by the first quarter of next year.