USFDA Committee votes in favour of clinical benefit of Roche's Polivy combination for people with previously untreated diffuse large B- cell lymphoma

More than 60 countries have approved this Polivy combination for the treatment of adult patients with previously untreated DLBCL, including in the EU, UK, Japan, Canada and China. Polivy in combination with R-CHP was recently added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 1, preferred regimen for first-line DLBCL.

DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin lymphoma in the US. Limited progress has been made in improving patient outcomes in previously untreated DLBCL over the last two decades. Polivy in combination with R-CHP is the first treatment in 20 years to show a significant improvement in progression-free survival (PFS) over the standard of care, MabThera/Rituxan in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), in this setting.

The sBLA submission is based on pivotal data from the phase III POLARIX study, which demonstrated a statistically significant and clinically meaningful improvement in PFS with Polivy plus R-CHP compared to standard-of-care R-CHOP in first-line DLBCL. The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP compared with R-CHOP (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; p<0.02). Safety outcomes were consistent with those seen in previous clinical trials, and the safety profile was comparable for Polivy plus R-CHP versus R-CHOP, including rates of Grade 3-4 adverse events (AEs; 57.7% versus 57.5%), serious AEs (34.0% versus 30.6%), Grade 5 AEs (3.0% versus 2.3%), and AEs leading to dose reduction (9.2% versus 13.0%).

Polivy in combination with bendamustine and MabThera/Rituxan is currently approved in more than 80 countries worldwide for the treatment of adults with relapsed or refractory DLBCL after one or more prior therapies, including in the US under FDA accelerated approval, as a readily available, fixed-duration treatment option .