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FDA grants priority review to Opdivo for classical Hodgkin lymphoma
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The FDA granted priority review to expand the use of nivolumab for the treatment of classical Hodgkin lymphoma after prior therapies.
The application included data from the phase 2 CheckMate-205 study, which evaluated the safety and efficacy of nivolumab (Opdivo, Bristol Meyers Squibb) — a PD-1 immune checkpoint inhibitor — in patients with classical Hodgkin lymphoma who received autologous stem cell transplant and brentuximab vedotin (Adcetris, Seattle Genetics). Opdivo previously received breakthrough therapy designation for this indication.
“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,” Jean Viallet, MD, Oncology Global Clinical Research lead at Bristol-Myers Squibb, said in a company-issued press release. “With the agency’s acceptance of our application, Opdivo 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.”
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, Bristol Meyers Squibb) 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.