- The FDA has approved Roche Group AG’s (OTC: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.
Elon Musk Reacts To Brittney Griner Prisoner Swap And Exclusion Of US Marine Paul Whelan
Elon Musk took to Twitter on Friday morning to opine about the Brittney Griner prisoner swap that brought the WNBA star home from a Russian prison in exchange for the convicted arms dealer,
