Clinical trial information for first-line follicular lymphoma



GAZYVA is a type of antibody therapy that targets and attaches to the CD20 proteins found on follicular lymphoma cells as well as some healthy blood cells.

What are the goals of treatment? 

Follicular lymphoma is not curable, but the disease can be managed over time. After initial treatment, your disease may progress (relapse) and require treatment again. In each stage of treatment, the goal is to relieve symptoms, stop the cancer from becoming worse, or achieve remission. 

Treatment goals and options depend on how much your symptoms are affecting you 

  • When you have no symptoms, close monitoring is usually preferred over treatment. This is often referred to as watchful waiting or active surveillance
  • When symptoms appear or worsen, treatment aims to stop the follicular lymphoma from progressing 

Follicular lymphoma can be treated in a number of ways, including antibody therapy and/or chemotherapy. Often, doctors will combine the 2 types of treatment. 

Once you begin treatment, your doctor will need to regularly check: 

  • Your symptoms 
  • The size of your lymph nodes, liver, or spleen 
  • Your blood count measures 

Follicular treatment options 

Treatments may vary from patient to patient and depend on various factors, including the stage of your disease, your age, and overall health. Although patients may respond initially, as many as 1 in 5 patients will relapse within 2 years of receiving their initial treatment therapy. Patients who experience such early relapse have poorer outcomes. 

Even after years in remission, follicular lymphoma can recur. When a relapse occurs, the cancer can become more difficult to treat. This means that preventing a patient’s disease from returning for as long as possible while minimizing disease symptoms is an important goal of initial treatment.


What results have been seen with the GAZYVA regimen? 

GAZYVA Clinical Study

The GAZYVA based regimen was studied in a trial of more than 1,200 patients with follicular lymphoma. 

  • Patients enrolled in the trial were given the GAZYVA based regimen or rituximab product-based regimen, another type of antibody-based treatment. The GAZYVA based regimen was GAZYVA + chemotherapy (bendamustine, CHOP, or CVP) followed by GAZYVA alone, in patients who responded. The rituximab product-based regimen was rituximab product + chemotherapy (bendamustine, CHOP, or CVP) followed by rituximab product alone, in patients who responded 
  • Patients studied had stage II bulky, III, or IV follicular lymphoma 

Goal of the clinical study 

The main goal of this study was to measure the length of time people lived without their follicular lymphoma getting worse (progression-free survival*)

Results of the study 

Patients were observed for an average of 38 months. Fewer patients had worsening of disease with the GAZYVA based regimen compared with patients who received the rituximab product-based regimen. The results highlighted below were from a clinical trial and may not be the same as what you experience.


Percentage of patients who had worsening of disease

CLL study results for GAZYVA + chlorambucil vs rituxi vs chlorambucil

*In the clinical trial, progression-free survival event was defined as disease progression or death.

Patient Brochure for Untreated Follicular Lymphoma

Learn more about untreated follicular lymphoma and what you can expect from GAZYVA

Download


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 follicular lymphoma treatment plans and can be given along with chemotherapy.

How it works

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

Chemotherapy


Chemotherapy is a drug treatment that destroys growing cells, including cancer cells. It is also an important part of follicular lymphoma 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.


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

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.

question mark icon

QUESTIONS FOR YOUR DOCTOR?

Explore questions you may want to ask your doctor.

telephone icon

Call our Patient Resource Center

1 (877) 218-3996

This is not meant to replace the advice of your healthcare team.

Indication

GAZYVA® (obinutuzumab) is a prescription medicine used in combination with chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III, or IV follicular lymphoma (FL) in adults who have not had previous FL 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 administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone are at a high risk of infections during and after treatment. 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. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP

  • 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

The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation and diarrhea

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