FDA Approves Opdivo for Hard-to-Treat Hodgkin Lymphoma

Written By:Hope Cristol

Patients with hard-to-treat Hodgkin lymphoma now have a new treatment option. The U.S. Food and Drug Administration granted accelerated approval to Opdivo (nivolumab) for classic Hodgkin lymphoma that has returned or progressed after a specific type of stem cell transplant and post-transplant medicine.

Hodgkin lymphoma is a cancer of the lymph system, which is part of the immune system. There are two main types of this disease, but “classic” Hodgkin lymphoma accounts for about 95% of all cases in developed countries. The American Cancer Society estimates about 8,500 new cases of Hodgkin lymphoma will be diagnosed in 2016, with a 5-year survival rate ranging from 90% for stage I to 65% for stage IV.

When Hodgkin lymphoma comes back after treatment (relapsed disease) or doesn’t go away after treatment (refractory disease), the next step is often an autologous stem cell transplant. This treatment uses high doses of chemotherapy, followed by reinfusing a patients’ own blood and marrow stem cells back into the body. The anticancer drug Adcetris (brentuximab vedotin) may be given to patients post-transplant.

Opdivo, an immunotherapy drug, can now be used for Hodgkin lymphoma if these treatments don’t work. In clinical trials that formed the basis of the new approval, 95 patients with relapsed or refractory disease were treated with Opdivo. It was found to shrink tumors in 65% of patients: 58% achieved partial remission and 7% achieved complete remission. The median duration of response – how long the positive results lasted – was 8.7 months.

The new approval for Hodgkin lymphoma is based only on Opdivo’s ability to shrink these tumors, but it is not yet clear if it can help people live longer. Common side effects in the studies included fatigue, upper respiratory tract infection, and diarrhea. Less common but more serious side effects are also possible.

Opdivo is in a new class of drugs called checkpoint inhibitors, which help your immune cells recognize and destroy cancer cells. Specifically, Opdivo blocks a protein on immune cells called PD-1. That protein actually helps cancer cells avoid detection. Blocking PD-1 means immune cells are better able to spot (and therefore attack) cancer.

In 2015 Opdivo was the first immunotherapy drug approved to treat non-small cell lung cancer. It is also used to treat advanced kidney cancer and advanced melanoma, and is being studied for use against a number of other cancers.

Opdivo is marketed by Bristol-Myers Squibb.

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