FDA Approves Polivy as First-Line Lymphoma Treatment

Roche has scored a win with the US Food and Drug Administration’s (FDA’s) approval of its drug Polivy for front-line diffuse large B-cell lymphoma (DLBCL). The approval comes after some reviewers were concerned about the benefits of the drug over the standard of care based on results from the phase III POLARIX study.

According to Phil Taylor, “The main study supporting the application – POLARIX – showed that the CD79b-directed antibody-drug conjugate (ADC) plus R-CHP achieved a 27% reduction in the risk of disease progression, relapse, or death, over a standard first-line regimen known as R-CHOP, although there was no statistically significant difference on overall survival. Around 40% of people with DLBCL relapse after initial therapy, so boosting responses in the front-line setting has the potential to provide big benefits to patients and reduce the need for later line therapies. For those patients that do relapse, the prognosis is poor, with a median overall survival of less than two years.”

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(Source: Pharmaphorum, April 20^th, 2023)