Polivy (polatuzumab vedotin-piiq), a novel antibody-drug conjugate, received approval to treat patients with diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab, the U.S. Food and Drug Administration announced today. The combination was approved for patients whose disease has progressed or returned after at least two previous therapies.

Approval was based on a study of 80 patients with relapsed or refractory DLBCL randomly assigned to receive either Polivy with bendamustine and rituximab or bendamustine and rituximab alone. Researchers found a complete response rate of 40 percent with Polivy plus bendamustine and rituximab compared with 18 percent with bendamustine and rituximab alone. Twenty-five patients achieved a partial or complete response with Polivy plus bendamustine and rituximab; 64 percent of these patients had a duration of response of six months or longer and 48 percent achieved a duration of response of at least one year.

The most commonly reported side effects of the combination of Polivy plus bendamustine and rituximab included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, decreased appetite, and pneumonia.

Patients should be closely monitored for infusion-related reactions, low blood counts, fatal or serious infections, tumor lysis syndrome, hepatotoxicity, and progressive multifocal leukoencephalopathy. The FDA noted that women of reproductive age should be advised to use effective contraception during treatment and for three months following the last dose, and those who are pregnant or breastfeeding should not be treated with Polivy.

Approval of Polivy was granted to Genentech.

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