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FDA Approves Nivolumab (Opdivo) for Advanced Hodgkin Lymphoma Patients

May 17, 2016

Today, the FDA approved the use of nivolumab (Opdivo)―an anti-PD-1 antibody―to treat classical Hodgkin lymphoma.

This is the first checkpoint immunotherapy approved for any type of lymphoma, and CRI is happy to know of one patient who has already benefited from this breakthrough: Ariella Chivil. Recently, CRI interviewed Ariella, whose Hodgkin lymphoma was successfully treated with nivolumab. Ariella’s oncologist—Alexander Lesokhin, M.D., Ph.D.—is a CRI scientist, who helped make this drug available for more patients through clinical trials.


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The approval was based on the results of two trials in which 95 patients with relapsed or refractory Hodgkin lymphoma were treated with the anti-PD-1 inhibitor. Of those 95 patients, 65% experienced positive responses after treatment.

CRI has been instrumental in the development of anti-PD-1 immunotherapies such as nivolumab. We funded research in four laboratories—those of Arlene Sharpe, M.D., Ph.D., Gordon Freeman, Ph.D., Lieping Chen, M.D., Ph.D., and Drew Pardoll, M.D., Ph.D.—that helped discover the pro-tumor PD-1 pathway and establish it as a new target for cancer immunotherapy drugs. For this groundbreaking work, CRI honored these researchers with the 2014 William B. Coley Award for Distinguished Research in Tumor Immunology.

Thanks in part to CRI's investments in research, nivolumab has already been approved for treatment of other advanced cancers, including melanoma, lung cancer, and kidney cancer. But this is the first time a checkpoint inhibitor has received approval for any type of lymphoma. This offers hope that this success can be extended to patients with other types of blood cancers, such as non-Hodgkin lymphoma and leukemia. These cancers often have different considerations and it can be harder to accurately monitor responses compared to solid tumor types.

This approval only covers patients who had previously been treated with a stem cell transplant and chemotherapy. All the patients in this study previously received transplants of their own stem cells. However, in cases where patients receive transplants from someone else, complications could arise. Since the donor’s stem cells would be “foreign” to the patient’s immune system, nivolumab immunotherapy could result in an immune response directed not only against the cancer, but also those transplanted stem cells. In light of this possibility, the FDA issued a “Warning and Precaution” to go along with the approval, and future efforts to treat these patients with checkpoint immunotherapy will have to be investigated thoroughly.

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