The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Bristol-Myers Squibb’s (BMS) investigational PD-1 immune checkpoint inhibitor nivolumab to treat patients with Hodgkin’s lymphoma (HL) after failure of autologous stem cell transplant and brentuximab.
Breakthrough therapy status is based on data from a group of patients with HL in the company’s ongoing Phase Ib trial of relapsed and refractory hematological malignancies.
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The breakthrough therapy designation is expected to speed-up the development and review of drugs for serious or life-threatening conditions.
Bristol-Myers Squibb senior vice-president of development, oncology and immunosciences Michael Giordano said 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.
"It is our goal to change the way patients live with cancer, especially in areas of high unmet medical need like Hodgkin’s lymphoma, where patients may be underserved by currently available treatment options," Giordano said.
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.
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By GlobalDataThe company is currently investigating whether by blocking this pathway, nivolumab would allow the immune system to resume its ability to recognise, attack and destroy cancer cells.
Hodgkin’s lymphoma (HL), also called as Hodgkin’s disease, is a cancer of the lymphatic system, which originates in white blood cells.
In the US, there is a five-year survival rate of 65% for advanced HL, which is one of two main types of lymphomas.
The company has a broad, global development programme to study nivolumab in multiple tumour types consisting of more than 35 trials as monotherapy or in combination with other therapies, which more than 7,000 patients have been enrolled worldwide.
