BristolMyers Squibb today announced that the U.S. Food and Drug Administration has accepted its New Drug Application for both CC-486, an investigational oral hypomethylating agent, for the care treatment of older patients with acute myeloid leukemia, that achieved complete remission or CR with in complete blood count healing, after induction therapy without augmentation therapy, and that aren't candidates for, or who opt to not move into, hematopoietic stem cell transplantation.
The NDA entry was based upon the effectiveness and safety outcomes of this critical Phase 3 QUAZAR® AML-001 analysis, that met the primary endpoint of improved overall survival for patients receiving AML care treatment with CC-486 versus placebo.
“Frequently, newly diagnosed elderly patients with AML reach a complete answer with induction therapy, yet many patients may relapse and also experience a bad results. Physicians in remission would like treatment choices which decrease the probability of relapse and expand overall survival,” stated Noah Berkowitz, M.D., Ph.D., senior vice president, Worldwide Clinical Development, Hematology, BristolMyers Squibb. “Now's approval of the entry for CC-486 represents a vital step to an expected new maintenance treatment to tackle an urgent health requirement for AML patients and people anticipate dealing together with the FDA throughout its own review of CC-486.”
The FDA granted priority review into Your New drug application to get CC-486 for your care treatment of patients with severe Incomplete blood count retrieval after induction therapy with Or without consolidation therapy, and that aren't candidates for, or even That opt to not check out, hematopoietic stem cell transplantation.
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