Positive FDA AdCom vote for Roche's Polivy in front-line lymphoma

Despite being presenting with briefing documents expressing some concerns about efficacy and safety, the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted 11 to 2 in favor of Polivy (polatuzumab vedotin-piiq) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL).

Developed and marketed by Swiss pharm giant Roche (ROG: SIX), Polivy has already won accelerated US approval for diffuse large B-cell lymphoma, in combination with rituximb and bendamustine, after at least two prior therapies. The drug is also approved in more than 90 countries, and has won a European approval for use in front-line patients based on the Phase III POLARIX study.

The advisers flagged Polivy’s lack of benefits in complete response and overall survival. At a median follow-up time of 39.7 months, the pola+R-CHP regimen only reduced the risk of death by 6% relative to R-CHOP, an effect that fell short of statistical significance.