For US Healthcare Professionals

POLIVY® is designed to treat relapsed or refractory DLBCL

POLIVY is a type of medicine that treats relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).

Who is POLIVY for?

POLIVY is an FDA-approved treatment for adults with DLBCL who have already received at least 2 prior therapies. It is used in combination with 2 other cancer treatments: bendamustine and a rituximab product.

POLIVY received an accelerated approval from the FDA. This conditional approval helps patients get earlier access to a promising drug while the company continues to conduct clinical trials to establish how well the drug works.

How does POLIVY work?

POLIVY is a type of medicine called an antibody-drug conjugate, or ADC. POLIVY is designed to work differently from traditional chemotherapies because it has the ability to find dividing B cells, including cancerous B cells.

Almost all B cells (including cancerous ones) have a marker on their surface called CD79b. POLIVY works by finding and attaching to B cells using the CD79b marker.

The POLIVY® (polatuzumab vedotin-piiq) antibody-drug conjugate (ADC) is designed to connect an anti-cancer drug with an engineered antibody

*Antibodies are also produced naturally by the body. They are a type of protein that acts as a natural defense system against disease.

Here is how POLIVY may work:

POLIVY® (polatuzumab vedotin-piiq) mechanism of action to induce internalization

POLIVY delivers an anti-cancer drug to the B cell by attaching to a CD79b B-cell surface marker.

POLIVY® (polatuzumab vedotin-piiq) mechanism of action to release anti-cancer drug into cell

After being taken into the B cell, POLIVY is broken down, releasing the anti-cancer drug inside the B cell.

POLIVY® (polatuzumab vedotin-piiq) - cancer cell death, healthy b cell

Once released, the anti-cancer drug in POLIVY causes the dividing B cells to die, including the cancerous ones. It may also harm healthy cells in the body.

Talk to your doctor about possible side effects. Please also see the full Prescribing Information for a complete list of possible side effects

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.