How POLIVY was studied

POLIVY plus a chemotherapy regimen of bendamustine and a rituximab product (POLIVY+BR) was compared with BR by itself in a clinical trial.

POLIVY was studied in 80 patients with R/R DLBCL

The people in the study were randomly placed into 2 separate treatment groups

POLIVY™ (polatuzumab vedotin-piiq) patient study design for GO29365

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.

In order to see how POLIVY works, patients in the study were also 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:

Had already received at least one prior treatment for their DLBCL
Were not candidates for a type of stem cell transplantation called HSCT
Were 30 to 86 years old (average age 69 years)

The study did not include people who had:

A history of moderate to severe nerve problems in their arms or legs
Prior treatment with certain types of stem cell transplantation
Central nervous system lymphoma* or transformed lymphoma^†

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.

Please talk to your doctor about whether POLIVY is right for you

Results in R/R DLBCL

POLIVY™ (polatuzumab vedotin-piiq) effectiveness icon - see the efficacy results of POLIVY+BR

See the efficacy results of POLIVY+BR

How Does POLIVY Work?

POLIVY™ (polatuzumab vedotin-piiq) icon for how it may work

Learn about how POLIVY was designed to treat R/R DLBCL

The Infusion Process

POLIVY™ (polatuzumab vedotin-piiq) icon for infusion process

See the infusion process and dosing schedule for POLIVY+BR

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 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.

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. 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.

Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you POLIVY, which may prevent some infections, and will monitor your blood counts throughout treatment with POLIVY. Treatment with POLIVY can cause severe low blood cell counts
Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication

Side effects seen most often

The most common side effects during treatment were

Low blood cell counts (platelets, red blood cells, white blood cells)
Nerve problems in arms and legs
Tiredness or lack of energy
Diarrhea
Nausea
Fever
Decreased appetite
Infections

POLIVY may not be for everyone. Talk to your doctor if you are

Pregnant or think you are pregnant: Data have shown that POLIVY may harm your unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking POLIVY. Women should use effective contraception during treatment and for at least 3 months after their last POLIVY treatment. Men taking POLIVY should use effective contraception during treatment and for at least 5 months after their last POLIVY treatment
Breastfeeding: Women should not breastfeed while taking POLIVY and for at least 2 months after the last dose

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.