An FDA advisory panel has voted in favor of expanding approval for 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).
The U.S. FDA’s Oncologic Drugs Advisory Committee 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. If the label expansion is approved, Polivy could be used in combination with Rituxan plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated DLBCL.
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
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."
Polivy, an anti-CD79b antibody-drug conjugate, was first approved in 2019 under an accelerated approval pathway for patients with relapsed or refractory DLBCL.
