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Talon Therapeutics Inc. (TLON), a biotechnology company with no mareted products, won the backing of a U.S. advisory panel for accelerated approval of its blood-cancer treatment.
The advisers voted 7-4 that the benefits of the anti-leukemia therapy called Marqibo outweigh its risks. The Food and Drug Administration is considering Marqibo, the San Mateo, California-based company’s lead product candidate, based on the second of three phases of clinical trials typically required for approval.
Talon would have to complete the final trials and prove the drug’s benefit if the FDA clears the treatment. The agency is due to decide by May 13. The therapy would treat adults with a form of acute lymphoblasticleukemia, a fast-growing cancer of the white blood cells.
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