Roche’s Polivy (polatuzumab vedotin-piiq) Combination Therapy Receives FDA’s Accelerated Approval for Relapsed/Refractory Lymphoma

Roche’s Polivy (polatuzumab vedotin-piiq) Combination Therapy Receives FDA’s Accelerated Approval for Relapsed/Refractory Lymphoma

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 30%); DOR lasting at least a year (48% vs 20%)
  • Polivy is an anti-CD79b anti-body drug conjugate and has received FDA’s PR designation in Feb’19 with FDA’s BT & EMA’s PRIME designation in 2017 for r/r DLBCL

Click here to read full press release/ article | Ref: Roche | Image: Ignition DG