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Bristol-Myers Squibb Co and Celldex Therapeutics Inc's Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma


Wednesday, 14 May 2014 05:00pm EDT 

Bristol-Myers Squibb Co and Celldex Therapeutics Inc:Says U.S. Food and Drug Administration (FDA) granted the investigational PD-1 immune checkpoint inhibitor nivolumab Breakthrough Therapy Designation.for treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant and brentuximab.designation is based on data from cohort of patients with HL in company's ongoing Phase 1b study of relapsed and refractory hematological malignancies.According to FDA, Breakthrough Therapy Designation is intended to expedite development and review of drugs for serious or life-threatening conditions.Criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. 

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