Cyclacel Pharmaceuticals Reaches Agreement With FDA

Cyclacel Pharmaceuticals, Inc. … Monday announced that it has reached agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment on the design of a pivotal Phase 3 trial for the Company’s sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia who are not candidates for intensive induction chemotherapy.
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