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Teva Pharmaceutical Industries

The U.S. Food and Drug Administration (FDA) granted its approval this week for TEVA Pharmaceutical’s new Leukemia treatment, TRISENOX® (arsenic trioxidec), according to a statement on the company’s website.

A medication administered by injection, TRISENOX® has been approved for use in combination with tretinoin for treatment of recently-diagnosed low-risk adults with acute promyelocytic leukemia (APL).

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The approval 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.

Three months ago Teva announced the medication was to be granted priority by the FDA, with a decision expected in the first quarter of 2018.

“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 VP 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 leukemia.”

The new indication reinforces the current practice guidelines by the National Comprehensive Cancer Network® (NCCN).

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Hana Levi Julian is a Middle East news analyst with a degree in Mass Communication and Journalism from Southern Connecticut State University. A past columnist with The Jewish Press and senior editor at Arutz 7, Ms. Julian has written for Babble.com, Chabad.org and other media outlets, in addition to her years working in broadcast journalism.