Bristol-Myers’ nivolumab receives US FDA Breakthrough Therapy designation for Hodgkin lymphoma

The US Food and Drug Administration has granted US drug major Bristol-Myers Squibb’s (NYSE: BMY) 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 Ib study of relapsed and refractory hematological malignancies.

According to the FDA, breakthrough 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.