FDA Approves Polivy for Large B-Cell Lymphoma

The FDA has granted accelerated approval to Polivy (polatuzumab vedotin-piiq, Genentech) to be used in conjunction with bendamustine and a rituximab product (BR product) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who have had at least two prior therapies. 

Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate that binds to the B-cell protein of the same name, thereby releasing the chemotherapy drug into the cells. 

“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 and acting director of the Office of Hematology and Oncology Products, in a statement.“Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked.”
 

The efficacy of polatuzumab vedotin-piiq was based on a study that included at least 80 patients with relapsed or refractory DLBCL and that evaluated complete response rates and duration of response (DOR), or the length of time the disease stays in remission. Patients were randomized to receive either polatuzumab vedotin-piiq with or without a BR product. 

In patients that received polatuzumab vedotin-piiq with a BR product, 40% achieved a complete response rate, compared with only 18% of patients who received only a BR. Out of the 25 patients who achieved a partial or complete response, 64% had a DOR of at least six months and 48% had a DOR of at least 12 months, according to an FDA statement. 

Major adverse reactions reported with the use of polatuzumab vedotin-piiq include neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia.

For patients with relapsed or refractory DLBCL, polatuzumab vedotin-piiq is to be administered at 1.8 mg/kg by intravenous infusion over 90 minutes every 21 days for six cycles, in combination with the BR product. If intolerated  subsequent infusions can be administered over 30 minutes. 

Prescribing information for polatuzumab vedotin-piiq warns healthcare providers to remain alert for instances of peripheral neuropathy, infusion-related reactions, myelosuppresion, serious and opportunistic infections, progressive multifocal leukoencephalopathy, tumor lysis syndrome, hepatotoxicity, and embryo-fetal toxicity that may develop in patients receiving treatment. 

DLBCL is a form of non-Hodgkin’s lymphoma. 

Click Here to Read the Full Prescribing Information      Click Here for Genentech’s Polivy Site