FDA to Consider Expanded Label for Nivolumab (Opdivo) for Treatment of Hodgkin’s Lymphoma Patients

Agency grants priority review

The FDA has accepted a supplemental biologics license application that seeks to expand the use of nivolumab (Opdivo, Bristol-Myers Squibb) to include patients with classical Hodgkin’s lymphoma (cHL) after prior therapies. The application included data from the CheckMate-205 trial, which evaluated nivolumab in cHL patients who received autologous stem cell transplant and brentuximab vedotin. The FDA granted the application a priority review.

Nivolumab currently has the following indications:

  • As a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma
  • As a single agent for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
  • In combination with ipilimumab (Yervoy, Bristol Myers-Squibb) for the treatment of patients with unresectable or metastatic melanoma
  • As a single agent for the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy
  • As a single agent for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy

Cancer cells may exploit regulatory pathways, such as checkpoint pathways, to hide from the immune system and shield tumors from immune attack. Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T cells. It blocks the binding of programmed death ligand-1 (PD-L1) and PD-L2, preventing the PD-1 pathway’s suppressive signaling on the immune system, including interference with an antitumor immune response.

In July 2014, nivolumab became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world.

Hodgkin’s lymphoma, also known as Hodgkin’s disease, is one of two main types of lymphoma. Hodgkin’s lymphoma is characterized by malignant lymphocytes called Reed-Sternberg cells. The other type of lymphoma is non-Hodgkin’s lymphoma, which is much more common. Hodgkin’s lymphoma affects nearly 190,000 people in the United States, with approximately 8,500 new cases and 1,120 deaths expected in 2016.

Source: Bristol-Myers Squibb; April 14, 2016.