Bristol-Myers Squibb is seeking to extend the current indications for Opdivo ( Nivolumab ) to include the treatment of patients with classical Hodgkin lymphoma ( cHL ) after prior therapies.
The application included CheckMate -205 data, which evaluated Nivolumab in patients with classical Hodgkin lymphoma who have received autologous stem cell transplant and Brentuximab vedotin ( Adcetris ).
CheckMate -205 is a Phase 2 study evaluating the safety and efficacy of Nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.
The results of this trial are expected to be presented at a medical meeting later this year.
In United States, The FDA ( Food and Drug Administration ) has granted the application a priority review, and previously granted Opdivo Breakthrough Therapy Designation for classical Hodgkin lymphoma on May 14, 2014.
Hodgkin lymphoma, which also is known as Hodgkin disease, is one of two main types of lymphoma, a group of cancers most often beginning in the lymph nodes.
Hodgkin lymphoma is characterized by malignant lymphocytes called Reed-Sternberg cells.
The other type of lymphoma is non-Hodgkin lymphoma, which is much more common.
In the European Union, about 12,200 new cases and 2,600 deaths are expected each year. There remains a significant unmet need for patients who have relapsed or have become refractory to current treatments.
Opdivo 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. ( Xagena )
Source: BMS, 2016