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FDA Accepts Supplemental Biologics License Application for Nivolumab in Classical Hodgkin Lymphoma, Grants Priority Review

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Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of nivolumab (Opdivo) to patients with classical Hodgkin lymphoma after prior therapies. The application included data from the CheckMate-205 clinical trial, which evaluated nivolumab in patients with classical Hodgkin lymphoma who have received autologous stem cell transplant and brentuximab vedotin (Adcetris). The FDA granted the application a priority review and previously granted nivolumab Breakthrough Therapy Designation for classical Hodgkin lymphoma on May 14, 2014.

“There is a significant burden on classical Hodgkin lymphoma patients who do not respond to initial treatment, and they need new treatment options that address the disease in a different way,” said Jean Viallet, MD, Oncology Global Clinical Research Lead, Bristol-Myers Squibb. “With the Agency’s acceptance of our application, [nivolumab] has the potential to be the first PD-1 inhibitor in hematology, allowing us to expand immuno-oncology beyond solid tumors to patients with classical Hodgkin lymphoma and strengthen our hematology franchise.”

CheckMate-205 is a phase II study evaluating the safety and efficacy of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma. Data from this trial are expected to be presented at a medical meeting later this year.

Nivolumab is indicated as a single agent for the treatment of patients with BRAF V600 wild-type and mutation-positive unresectable or metastatic melanoma; in combination with ipilimumab (Yervoy) for the treatment of patients with unresectable or metastatic melanoma; for the treatment of patients with metastatic non–small cell lung cancer with progression on or after platinum-based chemotherapy; and for the treatment of patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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