Tags : Accelerated

Regulatory

Roche’s Polivy (polatuzumab vedotin-piiq) Combination Therapy Receives FDA’s Accelerated Approval

Shots: The accelerated approval is based on P-Ib/II GO29365 study results involves assessing of Polivy + bendamustine + Rituxan (BR)/Gazyva (obinutuzumab) vs BR in patients with r/r follicular lymphoma or DLBCL with 2L+ treatment The P-Ib/II GO29365 study results: CRR (40% vs 18%); objective response (45% vs 18%); DOR lasting at least 6mos. (64% vs […]Read More