Nivolumab Gets FDA Approval For Classical Hodgkin Lymphoma

Nivolumab (marketed as Opdivo), Bristol-Myers Squibb’s immuno-oncology compound, has been given an accelerated approval by the FDA for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after prior therapies like autologous stem cell transplant or Adcetris.

Classical Hodgkin lymphoma or cHL is the most common type of Hodgkin lymphoma, 95% of cases. It can be subclassified into 4 pathologic subtypes based upon Reed–Sternberg cell morphology and the composition of the reactive cell infiltrate seen in the lymph node biopsy.

The approval is the first for a PD-1 inhibitor for any type of blood cancer. It was based on results from the Phase 1 CheckMate-039 and Phase 2 CheckMate-205 studies, which showed an overall response rate of 65% with a median duration of response of 8.7 months. Full results from -205 will be presented at the American Society of Clinical Oncology annual meeting in June.

Nivolumab works as a checkpoint inhibitor, blocking a signal that would have prevented activated T cells from attacking the cancer, the allowing the immune system to clear the cancer.

Nivolumab has previously been approved for other indications, including:

  • Melanoma that cannot be removed by surgery or that has metastasized (spread to other parts of the body).
    It is used with ipilimumab in patients whose cancer does not have a certain BRAF gene mutation. It is used alone in patients whose disease got worse after being treated with ipilimumab and, if their cancer had a certain BRAF gene mutation, with a drug called a BRAF inhibitor.
  • Non-small cell lung cancer that has metastasized. It is used in patients whose disease got worse during or after treatment with platinum chemotherapy. Patients whose cancer has certain gene mutations should receive nivolumab only if their disease got worse after treatment with FDA-approved therapy for the gene mutations.
  • Renal cell carcinoma (a type of kidney cancer) that is advanced. It is used in patients who have already received angiogenesis inhibitor therapy.

A new “Warning and Precaution” was also issued for complications of autologous hematopoietic stem cell transplantation (HSCT) after nivolumab. Transplant-related mortality has occurred, and health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions. The FDA required Bristol-Myers Squibb to further study the safety of allogeneic HSCT after nivolumab.

Photo: Lymph node biopsy showing Hodgkin’s lymphoma, mixed-cellularity type. Wiki Commons. CC BY-SA 3.0