FDA approves chemoimmunotherapy regimen in diffuse large B-cell lymphoma

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA granted accelerated approval to Polivy (polatuzumab vedotin-piiq), a novel antibody-drug conjugate, in combination with the chemotherapy bendamustine and rituximab product, to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.

FDA granted the approval of Polivy to Genentech. It granted the application Breakthrough Therapy and Priority Review designations. Polivy also received Orphan Drug designation.

Polivy is an antibody that is attached to a chemotherapy drug. Polivy binds to a specific protein (CD79b) found only on B cells, then releases the chemotherapy drug into those cells. Efficacy was evaluated in a study of 80 patients with relapsed or refractory DLBCL who were randomized to receive Polivy with BR or BR alone.

Efficacy was based on complete response rate and duration of response, defined as the time the disease stays in remission. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least six months and 12 (48%) had a DOR of at least 12 months.

YOU MAY BE INTERESTED IN

At the Sept. 4 meeting of the National Cancer Advisory Board, NCI Principal Deputy Director Douglas R. Lowy provided an overview of how NCI is weathering the maelstrom of executive orders, policy changes, and funding uncertainties that has come down on federal agencies and research institutes since Donald Trump’s inauguration in January. 
A Senate hearing that the administration hoped would be a routine check-in on the president’s 2026 MAHA-driven healthcare agenda erupted into a political firestorm as senators jumped at their first opportunity to confront HHS Secretary Robert F. Kennedy Jr. over the chaos engulfing the Centers for Disease Control and Prevention.
In December 1971, President Richard Nixon signed the National Cancer Act and declared a “War on Cancer.” In the past 54 years, the U.S. has invested $180 billion nominally, or approximately $322 billion when adjusted for inflation, in cancer research. This investment has paid dividends with more than 100 anticancer drugs brought to market in half a century—virtually all traceable to National Cancer Institute funding. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login