Opdivo nabs FDA approval in specific patients with Hodgkin lymphoma

pharmafile | May 18, 2016 | News story | Research and Development, Sales and Marketing Bristol-Myers Squibb, Hodgkin lymphoma, opdivo 

Bristol-Myers Squibb (NYSE: BMY) has announced that the US Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of specific patients with classical Hodgkin lymphoma marking the drug’s eighth approval in under two years in four distinct cancer types.

In recent times, the PD-1 inhibitor has been approved in indications such as advanced renal cell carcinoma and melanoma. This latest approval is indicated for the treatment of patients with classical Hodgkin lymphoma who has relapsed or progressed after autologous haematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.

Hodgkin lymphoma is a rare cancer of the lymphatic system where B-lymphocytes start to multiply in an abnormal way and begin to collect in certain parts of the system, such as lymph nodes. These affected lymphocytes lose their infection-fighting properties, making patients more vulnerable to infection.

This latest approval is based on Opdivos’ efficacy in the Phase I and Phase II CheckMate trials. Among patients in the trial, the drug achieved an objective response rate of 65%, with the duration of response maintained over time for a median of 8.7 months.

Chris Boerner, head of US commercial at BMS, says: “Today’s approval of Opdivo delivers a transformational and exciting new option for these patients and the haematologists who treat them. This is our second immune-oncology agent in blood cancer in less than a year for patients impacted by diseases with a deep unmet need.”

Anas Younes, medical oncologist and chief of lymphoma service at Memorial Sloan Kettering Cancer Center, comments: “It is important to have new treatment options for patients with difficult-to-treat diseases who have exhausted the current available options. Because of the unique pathology and biology of classical Hodgkin lymphoma, it makes sense from a scientific standpoint to investigate a PD-1 inhibitor. The recent clinical data with Opdivo… is encouraging and has the potential to impact our approach to treating these individuals in the future.”

Sean Murray

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