South San Francisco, CA — January 25th, 2023 —
Genentech will participate in the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting on March 9, 2023 to discuss the supplemental Biologics License Application (sBLA) for Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The sBLA submission is based on pivotal data from the Phase III POLARIX study, a multicentre, randomized, double-blinded, placebo-controlled clinical trial of more than 800 patients. Study results showed a 27% reduction in the risk of disease worsening or death with Polivy plus R-CHP compared to standard-of-care R-CHOP in first-line DLBCL. Overall survival data was immature. The safety profile was comparable for Polivy plus R-CHP versus R-CHOP*. The FDA is expected to make a decision on approval by April 2, 2023.
DLBCL is an aggressive, hard to treat disease and is the most common form of non-Hodgkin's lymphoma in the U.S. Four in ten people do not respond to treatment, and the majority of those who require subsequent lines of therapy have poor outcomes. Limited progress has been made over the last two decades in improving the current standard of care in the first-line setting. We look forward to continued collaboration with the FDA and discussions with the advisory committee to support the application process.
*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 U.S. Indication
Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least two prior therapies.
The accelerated approval of Polivy is based on a type of response rate. There are ongoing studies to confirm the clinical benefit of Polivy.
Important Safety Information
Possible serious side effects
Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. A patient’s doctor may stop or adjust a patient’s treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.
Side effects seen most often
The most common side effects during treatment were:
Polivy may not be for everyone. A patient should talk to their doctor if they are:
These may not be all the side effects. Patients should talk to their healthcare provider for more information about the benefits and risks of Polivy treatment.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please visit http://www.Polivy.com for the full Prescribing Information for additional Important Safety Information.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.