Roche’s Polivy (polatuzumab vedotin) Based Combination Regimen Receives EC’s Approval for Patients with R/R Diffuse Large B-Cell Lymphoma
Shots:
- The conditional approval is based on P-Ib/II GO29365 study assessing Polivy + bendamustine and MabThera (rituximab) (BR) or Gazyvaro (obinutuzumab) vs BR in R/R FL or DLBCL patients who are not the candidates for a hematopoietic stem cell transplant
- The P-Ib/II GO29365 study results: CR (40% vs 17.5%); improvement in OS (12.4 vs 4.7); the longer time between first response to treatment and disease worsening (10.3 vs 4.1 mos.)
- Polivy is an ADC targeting CD79b, developed by utilizing Seattle Genetics’ ADC technology and has received FDA’s BT and EMA’s PRIME designation to treat people with r/r DLBCL in 2017. The conditional approval follows the US FDA’s accelerated approval granted in Jun’2019
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