TUESDAY, 11 June 2019 (HealthDay News) – Polivy (polatuzumab vedotin-piiq), a new antibody-drug conjugate, received approval for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab, the US Food and Drug Administration announced today. The combination has been approved for patients whose disease has progressed or returned after at least two previous therapies.
The approval was based on a study of 80 patients with relapsed or refractory DLBCL who were randomly assigned to receive either Polivy with only bendamustine and rituximab or bendamustine and rituximab. Researchers found a full response rate of 40 percent with Polivy plus bendamustine and rituximab compared to 18 percent with only bendamustine and rituximab. Twenty-five patients achieved a partial or complete response with Polivy plus bendamustine and rituximab; 64 percent of these patients had a response time of six months or longer and 48 percent achieved a response time of at least one year.
The most commonly reported adverse reactions of the combination Polivy plus bendamustine and rituximab include neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, loss of appetite and pneumonia.
Patients should be closely monitored for infusion-related reactions, low blood counts, fatal or severe infections, tumor lysis syndrome, hepatotoxicity, and progressive multifocal leukoencephalopathy. The FDA noted that women of childbearing potential should be advised to use effective contraception during treatment and for three months after the last dose, and those who are pregnant or breastfeeding should not be treated with Polivy.
Polivy approval was granted to Genentech.
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