The FDA has approved Roche's Polivy combination to allow the regime to be used a first-line treatment option for patents with diffuse large B-cell lymphoma (DLBCL) — making it the first FDA-approved therapy in nearly 20 years for the indication.
The approval means that Polivy can be used in combination with Rituxan plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated DLBCL.
Polivy, an anti-CD79b antibody-drug conjugate, was first approved in 2019 under an accelerated approval pathway for patients with relapsed or refractory DLBCL. Back in March, an FDA advisory panel had voted 11 to 2 in favor of the clinical benefit of the phase 3 POLARIX study of Polivy in combination with R-CHP for people with previously untreated DLBCL. However, the FDA's briefing document shared prior to the AdComm meeting expressed concerns over just how clinically meaningful the trial data was, pointing to a "modest progression-free survival benefit."
DLBCL is an aggressive, hard-to-treat disease and the most common form of non-Hodgkin lymphoma in the U.S. According to Roche, Polivy is the first treatment in 20 years to show a significant and clinically meaningful improvement in progression-free survival over the standard of care for first-line DLBCL
The agency's decision on Wednesday also converted the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory (R/R) DLBCL after at least two prior therapies to regular approval.