AdComm backs lymphoma expansion for Roche drug

March 10, 2023

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.