FDA Approvals, News & UpdatesLymphomaNewsworthy

Polivy a New Targeted Immunotherapy Approved for Patients with B-Cell Lymphoma

In June 2019, the FDA approved a new type of immunotherapy called Polivy, for use in combination with other drugs, in patients with previously treated diffuse large B-cell lymphoma (DLBCL), offering new options for patients whose cancer has returned.
August 2019 Vol 5 No 4

In June 2019, the FDA approved Polivy (polatuz­umab vedotin-piiq; from Genentech), a new targeted immunotherapy called CD79b-directed antibody–drug conjugate, in combination with the immunotherapy Rituxan (rituximab; from Genentech; or a biosimilar of Rituxan) plus the chemotherapy bendamustine, for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more therapies.

“Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer. This type of therapy, unlike traditional chemotherapy, is intended to target specific cells,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked.”

The FDA approved Polivy based on a clinical trial showing that in patients with relapsed or refractory DLBCL who received Polivy plus the chemoimmunotherapy combination, the tumor responded much better than in patients who received chemotherapy plus Rituxan but without Polivy. In fact, some of those patients had no signs of lymphoma for 12 months or longer.

The most common side effects with Polivy were low white blood cells, anemia, peripheral neuropathy, fatigue, diarrhea, fever, low appetite, and pneumonia.

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Last modified: September 3, 2019

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