Polivy Approved to Treat B-Cell Lymphoma
June 10, 2019 – The U.S. FDA has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq), manufactured by Genentech. The drug is indicated for use in combination with bendamustine and rituximab (BR) to treat adults who have relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and who have received at least two prior therapies. Polivy is a first-in-class antibody-drug conjugate that targets CD79b, a protein expressed by the majority of B-cells.
DLBCL is a fast-growing cancer of the blood cells, and the most common form of non-Hodgkin’s lymphoma (NHL) in the United States. An estimated 18,000 individuals are diagnosed with DLBCL in the U.S. each year. Although the disease often responds well to initial treatment, approximately 40% of patients will relapse. The prognosis for relapsed or refractory disease is often poor.
In a clinical study, Polivy used in combination with BR became the only treatment to date to show higher clinical response rates compared to BR, a commonly used regimen, in patients who have relapsed or refractory DLBCL and are ineligible for a hematopoietic stem cell transplant. Forty percent of patients who received Polivy plus BR achieved a complete response, meaning no cancer could be detected, compared to 18% of patients who received BR alone. Forty-five percent of patients treated with Polivy and BR achieved an objective response, while 18% of patients treated with BR alone achieved the same. Patients who received Polivy and BR were also more likely (64% versus 30%) to achieve a duration of response of at least six months, and were more likely to have a duration of response of at least a year (48% versus 20%).
Recommended dosing is 1.8mg/kg of Polivy given as an intravenous (IV) infusion over the course of 90 minutes every 21 days for a total of six cycles in combination with BR. If the first infusion is tolerated, administration time can be shortened to 30 minutes for subsequent treatments. Patients should be pre-medicated with an antihistamine and antipyretic before every infusion.
Because the FDA granted accelerated approval, continued approval for Polivy may require verification and description of clinical benefit in a confirmatory trial. Polivy has launched at an average wholesale price (AWP) of $18,000 per vial.