Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma

Bristol-Myers Squibb Company has announced that FDA has granted the investigational PD-1 immune checkpoint inhibitor nivolumab Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant and brentuximab. The designation is based on data from a cohort of patients with HL in the company’s ongoing Phase 1b study of relapsed and refractory hematological malignancies.

According to FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The 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.

“The Breakthrough Therapy Designation granted by FDA for nivolumab continues to support the development of innovative approaches designed to advance how cancer is treated,” said Michael Giordano, senior vice president, Head of Development, Oncology & Immunosciences. “It is our goal to change the way patients live with cancer, especially in areas of high unmet medical need like Hodgkin lymphoma where patients may be underserved by currently available treatment options.”