FDA approves chemoimmunotherapy regimen for patients with relapsed or refractory DLBCL

FDA granted on Monday accelerated approval to polatuzumab vedotin-piiq (Polivy—Genentech), in combination with the chemotherapy bendamustine and a rituximab product (together known as BR), for the treatment of adults with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.

FDA granted on Monday accelerated approval to polatuzumab vedotin-piiq (Polivy—Genentech), in combination with the chemotherapy bendamustine and a rituximab product (together known as BR), for the treatment of adults with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. DLBCL is the most common type of non-Hodgkin lymphoma. "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 FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. A clinical trial of 80 patents with relapsed or refractory DLBCL found that at the end of treatment, the complete response rate was 40% with polatuzumab vedotin-piiq plus BR, compared with 18% for only BR. Sixteen of the 25 patients who achieved a partial or complete response to the combination therapy had a duration of response (DOR) of at least 6 months, while 12 had a DOR of at least 12 months. The most common adverse effects of olatuzumab vedotin-piiq plus BR were low levels of white blood cells, platelets (thrombocytopenia) and red blood cells (anemia); nerve damage (peripheral neuropathy); fatigue; diarrhea; fever; decreased appetite; and pneumonia. FDA noted that health care professionals should monitor patients for infusion-related reactions, low blood counts and fatal and/or serious infections. Additionally, they should be alert for tumor lysis syndrome, liver damage, and progressive multifocal leukoencephalopathy.