Genentech's ADC Polivy Receives FDA Accelerated Approval, Doubling Complete Response Rate in Relapsed/Refractory DLBCL

Today, the U.S. FDA announced accelerated approval of Genentech’s antibody-drug conjugate Polivy (polatuzumab vedotin-piiq) for use in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.FDAIt was noted that this is also the first chemoimmunotherapy for this disease.

Diffuse large B-cell lymphoma, abbreviated as DLBCL, is the most common type of non-Hodgkin lymphoma. It is estimated that more than 18,000 new cases of DLBCL are diagnosed annually in the United States. Although the condition can be effectively controlled after initial treatment in many patients, 30%–40% of patients will ultimately experience disease relapse.

Polivy, an antibody-drug conjugate (ADC) granted accelerated approval today, targets the CD79b protein specifically expressed on the surface of B cells at one end and is linked to a chemotherapy agent at the other. As designed, upon specific binding to and internalization into B cells in vivo, it releases the chemotherapy drug to kill the cells, thereby controlling cancer progression.

In a Phase 1b/2 clinical trial, the efficacy of Polivy was validated. The trial evaluated 80 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who were randomized into two groups: one receiving standard treatment with bendamustine and rituximab, and the other receiving Polivy in addition to this regimen. Study results showed that the complete response rate in the standard treatment group was 18%. In the Polivy-treated group, this figure reached 40%, more than double. Furthermore, among patients in the Polivy group who achieved partial or complete response, 64% maintained their response for more than six months, and nearly half (48%) sustained it for over a year. In its press release, Genentech pointed out that this is also the only randomized pivotal study demonstrating a higher response rate compared to this standard therapy.Clinical Trial。

Based on these outstanding results, the U.S. FDA today granted accelerated approval for Polivy in combination with standard therapy for the treatment of patients with refractory lymphoma. Previously, it had also received U.S.FDABreakthrough Therapy Designation, Priority Review Status, and Orphan Drug Designation granted.

“Antibody-drug conjugates are a novel class of cancer-targeted therapies. Unlike traditional chemotherapy, they can target specific cells,” the United StatesFDADr. Richard Pazdur of the Center for Drug Evaluation and Research stated, “The approval of Polivy today provides a new treatment option for patients who have not responded to multiple prior therapies.”

“Despite significant progress in the treatment of DLBCL, therapeutic options remain very limited for patients whose disease becomes resistant or relapses after multiple lines of therapy,” commented Dr. Sandra Horning, Chief Medical Officer and Head of Global Product Development at Genentech. “The approval of Polivy combination therapy today will bring a novel treatment option, providing immediate benefit to those patients with urgent unmet needs.”

We congratulate the accelerated availability of this innovative combination therapy to patients, and we look forward to it bringing new hope to many patients!Bio ValleyBioon.com）