FDA advisers question efficacy of Roche’s Polivy in first line LBCL

The FDA has raised concerns regarding the efficacy and risk-benefit profile of Genentech (Roche)’s Polivy (polatuzumab vedotin-piiq) as a first-line treatment for large B-cell lymphoma (LBCL).

These issues were raised in briefing documents published ahead of an Oncologic Drugs Advisory Committee (ODAC) meeting set for March 9. The panel of external experts called Polivy’s progression-free survival (PFS) benefit “modest” in this indication. The advisers also noted the lack of improvement in overall survival (OS) and complete response (CR).