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Recent Immunotherapy Approvals from the FDA

January 3, 2019

Over the past year, the U.S. Food and Drug Administration has approved an expanding array of immunotherapy treatments for more types of cancer. Ongoing clinical trials are expected to lead to more approvals.

Non-Hodgkin lymphoma
Two rare forms of the cancer, primary cutaneous anaplastic large cell lymphoma and CD30-expressing mycosis fungoides, can now be treated with brentuximab vedotin.

Advanced kidney cancer
The combination of two immunotherapies, nivolumab and ipilimumab, was approved as an initial treatment for some patients with advanced kidney cancer.

Cervical cancer and lymphoma
The immunotherapy, pembrolizumab, was approved for expanded use for advanced cervical cancer and for treatment-resistant primary mediastinal large B-cell lymphoma.

Metastatic colorectal cancer
Two immunotherapy drugs, ipilimumab and nivolumab, were approved for patients with metastatic colorectal cancer whose tumor cells have defects that affect their ability to repair DNA.

Hairy cell leukemia
Moxetumomab, an immunotoxin that binds a portion of an antibody to a toxin so the toxin can be released into the cancer cell, was approved for patients with hairy cell leukemia who don’t respond to other treatments.