FDA Approves Combo of Arsenic Trioxide and Tretinoin for APL

The U.S. Food and Drug Administration (FDA) approved the combination use of arsenic trioxide (Trisenox) injection plus tretinoin, also known as all-trans retinoic acid (ATRA), as a first-line treatment for adults with newly diagnosed low-risk acute promyelocytic leukemia (APL).

In particular, the treatment is intended for patients whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

"Today's approval to expand the indication of Trisenox is a testament to Teva’s commitment to providing solutions to advance cancer care," Paul Rittman, Senior Vice President and General Manager of Teva Oncology, said in a press release. "This label expansion represents an important benefit as Trisenox is now an FDA-approved first line treatment option for patients with acute promyelocytic leukemia."

APL is a subtype of acute myeloid leukemia (AML), where there is an abnormal accumulation of granulocyte precursors called promyelocytes.

Arsenic trioxide is also currently indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.