FDA expands indication of Teva’s Trisenox for acute promyelocytic leukaemia
Teva has announced that its Trisenox (arsenic trioxide) injection has been awarded US approval from the FDA in combination with tretinoin for the treatment of newly-diagnosed low-risk acute promyelocytic leukaemia (APL) in adult patients whose APL is characterised by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
The decision expands upon the drug’s existing approval for acute promyelocytic leukaemia patients resistant to retinoid and anthracycline chemotherapy. The good news will come as some brief respite for the Israeli company, which is currently languishing in its financial woes – just this year, the firm has settled a multi-million dollar international bribery case with the Israeli authorities, and its executives have been forced to accept a reduction in their salaries by half to cut costs.
“Today’s approval to expand the indication of Trisenox is a testament to Teva’s commitment to providing solutions to advance cancer care,” said Teva Oncology Senior Vice President and General Manager Paul Rittman. “This label expansion represents an important benefit, as Trisenox is now an FDA-approved first line treatment option for patients with acute promyelocytic leukaemia.”
Teva originally picked up Trisenox with its acquisition of Cephalon in 2011.
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