People who received POLIVY+BR had a complete remission or a partial remission more often compared with those who received BR by itself.
63% of the people who received POLIVY+BR had a complete or partial remission at some point in the study (25 out of 40), compared with 25% of those who received BR by itself (10 out of 40).
*Doctors in the study checked response to treatment 6 to 8 weeks after Day 1 of cycle 6 or last study treatment.
Of the 10 people who responded to BR treatment by itself, 20% had a DoR of at least 12 months (2 out of 10), and 30% had a DoR of at least 6 months (3 out of 10).
Duration of response (DoR) is the length of time a person is in remission, from where they first respond to treatment to when the disease gets worse. DoR includes people who have had a complete remission or partial remission at any time in the study.
POLIVY plus a chemotherapy regimen of bendamustine and a rituximab product (POLIVY+BR) was compared with BR by itself in a clinical trial. It was studied in 80 patients with R/R DLBCL.
Patients received either POLIVY+BR or BR by itself every 21 days for 6 treatment cycles. Both patients and healthcare providers knew which treatment had been given.
Patients in the study were randomized (or sorted) by the length of time they responded to a previous treatment (also known as duration of response, or DoR).
The study included patients with R/R DLBCL who:
The study did not include people
HSCT=hematopoietic stem cell transplantation.
*Central nervous system lymphoma is a rare non-Hodgkin lymphoma in which cancer cells from other parts of the body form in the brain and/or spinal cord.
†Transformed lymphoma occurs when a slow-growing lymphoma develops into a more aggressive one.
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 2 prior therapies.
The conditional approval of POLIVY is based on a type of response rate. There are ongoing studies to establish how well the drug works.
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. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your 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. Talk to your doctor if you are
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of POLIVY treatment.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Please see the full Prescribing Information for additional Important Safety Information.
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