Novartis Pharmaceuticals' experimental T-cell therapy for acute lymphocytic leukemia was unanimously recommended for approval by the FDA's 10-member advisory panel, taking it a step closer to being the first immunotherapy to become commercialized. The panel also proposed that Novartis undertake a 15-year monitoring period that would include information on relapses with secondary cancers. The FDA could grant approval by the fall, and the next challenge would be to persuade insurers to cover the high costs of such personalized treatments.
Novartis' gene therapy for leukemia receives support from FDA committee
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