Roche Receives FDA Approval for Polivy in Relapsed or Refractory Follicular Lymphoma

Roche today announced that the FDA has approved Polivy (polatuzumab vedotin-piiq) in combination with obinutuzumab and lenalidomide for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after at least two prior lines of therapy. In the Phase 3 POLARIX-FL trial, the combination demonstrated a statistically significant improvement in progression-free survival compared to obinutuzumab and lenalidomide alone. The 2-year PFS rate was 68.5% for Polivy plus obinutuzumab and lenalidomide versus 55.3% for the comparator. This approval expands Polivy's use into follicular lymphoma.