FDA says Teva’s Trisenox injection for certain acute promyelocytic leukemia can be used in combination with tretinonJanuary 16, 2018
Israel’s largest drugmaker, and world’s renown generic drug’s leading producer Teva, through it’s USA outpost Teva Ltd, said that that the U.S. Food and Drug Administration (FDA) has approved the use of Trisenox injection for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL).
Teva noted that the approval of this arsenic trioxide in combination with tretinoin was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide. Furthermore, this approval is for the patients whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Paul Rittman, Senior Vice President and General Manager, Teva Oncology, said: “Today’s approval to expand the indication of TRISENOX is a testament to Teva’s commitment to providing solutions to advance cancer care. This label expansion represents an important benefit as TRISENOX is now an FDA-approved first line treatment option for patients with acute promyelocytic leukemia.”
Differentiation syndrome and cardiac conduction abnormalities
Teva said in its press release about the FDA’s approval that patients with acute promyelocytic leukemia (APL) treated with TRISENOX have experienced symptoms of differentiation syndrome, which can be fatal if not treated. The company warned that symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain or peripheral edema, hypotension, and renal, hepatic, or multi-organ dysfunction, in the presence or absence of leukocytosis. As a safety measure, the company said that if differentiation syndrome is suspected, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Temporary discontinuation of TRISENOX may be required.
In addition, Teva also warned about cardiac conduction abnormalities. It said that arsenic trioxide can cause QTc interval prolongation, complete atrioventricular block, and a torsade de pointes-type ventricular arrhythmia, which can be fatal. Before initiating therapy, assess the QTc interval, correct pre-existing electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Therefore, do not administer TRISENOX to patients with ventricular arrhythmia or prolonged QTcF.
Image: A building belonging to Teva Pharmaceutical Industries, the world’s biggest generic drugmaker and Israel’s largest company, is seen in Jerusalem February 8, 2017. REUTERS/Ronen Zvulun