Outside advisers to the Food and Drug Administration have backed expanding use of Roche’s drug Polivy, voting 11-2 Thursday in favor of approving it for patients newly diagnosed with the most common type of non-Hodgkin lymphoma.
If the FDA follows the advisory committee’s advice, as it usually does, Polivy would be cleared for first-line use in patients with diffuse large B cell lymphoma alongside a commonly used regimen called R-CHOP that has been the standard of care since 2006. An OK from the regulator would also convert the conditional nod Polivy received as a third-line treatment in 2019 to a full approval.
