Breakthrough Designation for Compound for Relapsed or Refractory Hodgkin's


Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has granted their latest potential treatment for some Hodgkin's patients Breakthrough Therapy Designation.

The company has received the designation for its investigational PD-1 immune checkpoint inhibitor nivolumab, based on data from a cohort of patients with HL in the company's ongoing Phase 1b study of relapsed and refractory hematological malignancies.

Nivolumab is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.

Bristol-Meyers Squibb is exploring the compound for the treatment of patients with Hodgkin's lymphoma (HL) who have had both an autologous stem cell transplant and received brentuximab (Adcetris).

"The Breakthrough Therapy Designation granted by the 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."

Source: WSJ

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