Nivolumab Granted Accelerated Approval for the Treatment of Classical Non-Hodgkin Lymphoma

The Backstory

On May 14, 2014, the immunotherapy drug nivolumab (Opidivo) received the FDA Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma whose disease relapsed after autologous stem cell transplant and treatment with brentuximab vedotin. Almost exactly two years later, on May 17, 2016, the FDA granted nivolumab accelerated approval for the treatment of people with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin

What is nivolumab?

Nivolumab is the first PD-1 blocking antibody approved for the treatment of a hematologic malignancy. Nivolumab inhibits a protein called PD-1. PD-1 primarily functions as an immune checkpoint, reducing the body’s natural immune response. PD-1 blockers like nivolumab interfere with PD-1 function and allow a person’s own immune system to destroy cancer cells; i.e., PD-1 blockers help the immune system to kill cancer.

Why did the FDA grant nivolumab the accelerated approval designation?

Nivolumab was granted an accelerated approval by the FDA based on results from two clinical trials in adults with relapsed or refractory Hodgkin lymphoma. In one study of 95 patients that had previously undergone autologous stem cell transplantation and brentuximab vedotin, 65% of people responded to nivolumab, with this response lasting almost 9 months on average. The FDA evaluated the safety of nivolumab in 263 patients treated on the second study. As is the case with all accelerated approvals, continued approval will be contingent upon the confirmed clinical results of a randomized phase III trial.

Were there any side effects?

Immune-mediated side effects occurred in 1% to 5% of patients and included rash, pneumonitis (inflammation of the lung), hepatitis (inflammation of the liver), hyperthyroidism, and colitis (inflammation of the intestine). Serious side effects were reported by 21% of patients. Additionally, the FDA issued a “Warning and Precaution” notice for patients who receive nivolumab followed by an allogeneic stem cell transplant. This was due to an increase in complications after allogeneic transplant that may be related to nivolumab. The FDA advises health care professionals to closely follow patients who receive nivolumab followed by allogeneic stem cell transplant for any complications. They have also required further study on the safety of allogeneic HSCT after nivolumab by the drug sponsor.

How can you access nivolumab now?

As an FDA approved drug, nivolumab can be prescribed by any qualified health care professional.

In addition to standard clinical use, at Weill Cornell Medicine we are continuing to study nivolumab and other immunotherapy drugs. For more information about nivolumab or immunotherapy drugs in general, please contact us at 212-746-2919 to make an appointment or with any questions regarding clinical trials or sign up for our newsletter.

FDA Approves Brentuximab for Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma

By Rebecca Elstrom, MD

The FDA granted accelerated approval last week to brentuximab vedotin for use in patients with Hodgkin lymphoma (HL) which has relapsed after 2 prior therapies, and patients with anaplastic large T cell lymphoma (ALCL) which has relapsed after one prior treatment. Weill Cornell Medical College participated in the studies that led to the approval.

Brentuximab vedotin is an antibody-drug conjugate (ADC); that is, a chemotherapy drug which has been attached to a monoclonal antibody in order to deliver the drug more specifically to target cells. In this case, the ADC targets CD30, a protein on the surface of the malignant HL cells and ALCL. Two phase 2 clinical studies were recently completed evaluating activity of brentuximab vedotin in HL patients who had had recurrence following autologous stem cell transplant and in ALCL patients that had relapsed after prior therapy. Response in both patient groups was striking. In HL, 73% of patients responded to treatment, with 32% achieving complete remission.  In ALCL, 86% of patients responded, with 57% achieving complete remission.

Major side effects of brentuximab vedotin in both groups of patients consisted of peripheral neuropathy, decreased blood counts, fatigue, nausea, rash and fever.

While long term results are still under investigation, initial response rates indicate that this drug represents an important new tool in the care of patients without other standard treatment options. Further studies are ongoing investigating how best to incorporate brentuximab vedotin into the routine care of patients with these lymphomas.

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