Bristol-Myers Squibb announced that the FDA has granted nivolumab, a PD-1 immune checkpoint inhibitor, Breakthrough Therapy designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab.
Nivolumab was granted this designation based on data from a cohort of patients with Hodgkin lymphoma in an ongoing Phase 1b study of relapsed and refractory hematological malignancies. A global development program, consisting of more than 35 trials has been developed to study nivolumab in multiple tumor types. Among these are several potentially registrational trials in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma.
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. BMS is investigating whether by blocking this pathway, nivolumab would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.
In 2013, the FDA granted Fast Track designation for nivolumab in NSCLC, melanoma, and RCC.
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