FDA Approves Roche's Polivy Combo Therapy For Untreated Patients With Diffuse Large B-Cell Lymphoma

  • The FDA has approved Roche Group AG's RHHBY Genentech's Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for previously untreated diffuse large B-cell lymphoma (DLBCL). 
  • The approval covers DLBCL patients not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of two or greater.
  • Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, the most common form of non-Hodgkin's lymphoma in the U.S.
  • This FDA decision converts the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory (R/R) DLBCL after at least two prior therapies to regular approval.
  • The FDA approval is based on data from POLARIX Phase 3 trial that demonstrated a statistically significant and clinically meaningful improvement in PFS compared to R-CHOP. 
  • The risk of disease progression, relapse, or death was reduced by 27% with Polivy plus R-CHP.
  • This approval follows the FDA Oncologic Drugs Advisory Committee (ODAC) vote of 11 to 2 in favor of Polivy in combination with R-CHP for previously untreated DLBCL.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechLarge CapNewsHealth CareFDAGeneralBriefs
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!