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Nivolumab Receives FDA ‘Breakthrough Therapy’ Designation for Hodgkin Lymphoma

Early trial evaluates PD-1 immune checkpoint inhibitor

The FDA has granted a “breakthrough therapy” designation to the investigational programmed death-1 (PD-1) immune checkpoint inhibitor nivolumab (Bristol-Myers Squibb) for the treatment of patients with Hodgkin lymphoma (HL) after the failure of treatment with autologous stem-cell transplant and brentuximab (Adcetris, Seattle Genetics).

The designation is based on data from a cohort of patients with HL in an ongoing phase Ib study of patients with relapsed and refractory hematologic malignancies.

According to the FDA, a “breakthrough therapy designation” is intended to expedite the development and review of medications for serious or life-threatening conditions. To receive this designation, a drug must show preliminary clinical evidence that it may offer substantial improvement on at least one clinically significant endpoint compared with available therapy.

Nivolumab is an investigational fully human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells. Research is under way to determine whether, by blocking this pathway, nivolumab would enable the immune system to resume its ability to recognize, attack, and destroy cancer cells.

HL is a cancer of the lymphatic system that originates in leukocytes. It is one of two main types of lymphoma. In the U.S., the 5-year survival rate for advanced HL is approximately 65%. If patients with relapsed or refractory HL progress within 1 year after receiving autologous stem-cell transplant (the standard of care), median survival is only 1.3 years after progression. The median age at diagnosis of HL is 38 years in the U.S. Experts have estimated that more than 9,100 new cases will be diagnosed in 2014, with more than 1,100 deaths expected.

Source: Bristol-Myers Squibb; May 14, 2014.

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