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Clinical Trial Information for Chronic Lymphocytic Leukemia (CLL)

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Clinical Trial Results
Antibody Therapy vs Chemotherapy
Financial Assistance

What results have been seen with GAZYVA® (obinutuzumab)? 

How patients responded to GAZYVA + chlorambucil chemotherapy vs rituximab product + chlorambucil 

In a clinical trial, the combination of GAZYVA and chlorambucil was studied against the combination of rituximab product and chlorambucil. Rituximab product is another antibody therapy, and chlorambucil is a type of chemotherapy. The results highlighted below were from a clinical trial and may not be the same as what you experience. 

GAZYVA taken with chlorambucil chemotherapy versus rituximab product + chlorambucil allowed some patients in the study to experience a median of 26.7 versus 14.9 months, respectively, without their cancer getting worse.
CLL study results for GAZYVA vs rituximab product

These results were from a clinical trial and may not be the same as what you experience.

What is the most important safety information I should know about GAZYVA?

Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:

  • Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes 
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Nearly 80% of patients had a partial or complete response to GAZYVA + chlorambucil chemotherapy vs rituximab product + chlorambucil. Your doctor may refer to this as remission.

CLL study results for GAZYVA + chlorambucil vs rituximab vs chlorambucil

These results were from a clinical trial and may not be the same as what you experience.

Remission can be partial or complete. Partial remission means the cancer is greatly improved, but evidence of cancer remains. Complete remission means all evidence of the cancer is gone for a period of time.

More than 1 in 4 patients who took GAZYVA + chlorambucil chemotherapy vs rituximab product + chlorambucil went into complete remission* for a period of time.
CLL study results on complete remission with GAZYVA® (obinutuzumab)
  • *Includes complete response with incomplete bone marrow recovery.

These results were from a clinical trial and may not be the same as what you experience.

This study included 781 patients:

  • Eight out of 10 patients in the study were 65 years or older
  • They were an average age of 73 years

Patients had other medical conditions such as:

  • High blood pressure
  • Diabetes
  • Heart or kidney conditions

Antibody therapy and chemotherapy

Antibody therapy

Antibody therapy is used to find and destroy specific cells within the body. It can use your body’s immune system to help fight cancer. It can also harm healthy cells in the body. It is often an important part of chronic lymphocytic leukemia treatment plans and can be given along with chemotherapy.

How it works

Antibody therapy targets a protein found on the surface of chronic lymphocytic leukemia cells and some healthy blood cells. It is thought to use your body’s immune system to find and kill leukemia and healthy cells.

Chemotherapy

Chemotherapy is a drug treatment that destroys growing cells, including cancer cells. It is also an important part of chronic lymphocytic leukemia treatment plans. It can be given as a single drug or a combination of drugs including antibody therapy.

How it works

Chemotherapy attacks growing cancer cells in the body. It also attacks growing healthy cells in the body, such as those for hair and the intestinal lining.

Financial Assistance 

No matter what type of health insurance you have, and even if you have none at all, there may be financial assistance options available. Take a look at the details and benefits of the available programs below.

Learn about available financial support
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Important Safety Information and Indications

Indication

GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
 

What is the most important safety information I should know about GAZYVA?

Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:

  • Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes

  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Who should not receive GAZYVA?

  • Do NOT receive GAZYVA if you have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past

What are the additional possible serious side effects of GAZYVA?

Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:

  • Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any GAZYVA infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the IRR is life-threatening, the infusion of GAZYVA will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each GAZYVA treatment. Symptoms of IRRs may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort

  • Hypersensitivity Reactions Including Serum Sickness: Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA

  • Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure requiring the need for dialysis treatment. Your doctor may prescribe medication to help prevent TLS. Your doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness

  • Infections: While you’re taking GAZYVA, you may develop infections. Some of these infections may be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA

  • Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections

  • Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced

  • Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor as it can lead to uncontrollable bleeding

The most common side effects of GAZYVA in CLL were infusion-related reactions and low white blood cell counts.

What other information should I tell my doctor before receiving GAZYVA?

You should talk to your doctor about:

  • Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines

  • Pregnancy: Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. GAZYVA may harm your unborn baby. Speak to your doctor about using GAZYVA while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after your GAZYVA treatment

  • Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, women should not breastfeed while taking GAZYVA and for 6 months after your last dose

Tell your doctor about any side effects.

These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.

GAZYVA is available by prescription only.

You may report side effects to the FDA at (800) FDA-1088, or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the accompanying full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.