FDA Approves GazyvaTM for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
On November 1st, 2013, the FDA approved GazyvaTM (obinutuzumab) Injection in combination with chlorambucil for the treatment of people with previously untreated CLL.
News in brief
- Gazyva is a monoclonal antibody designed to attach CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body's immune system.
- Gazyva is the fifth cancer medicine from Genentech approved by the FDA in the past three years.
- Gayzva is the first medicine approved with the FDA’s Breakthrough Therapy Designation.
Press ReleaseNovember 1, 2013 - FDA Approves Gazyva (obinutuzumab) for People with Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Understanding CLLChronic lymphocytic leukemia is the most common type of adult leukemia. Learn more.
Important Safety Information including BOXED WARNINGS
Patients must tell their doctor right away about any side effects they experience. GAZYVA can cause side effects that can become serious or life-threatening including:
Hepatitis B Virus (HBV) Reactivation:may cause serious liver problems including liver failure and death. If patients have had hepatitis B or are carriers of HBV, receiving GAZYVA could cause the virus to become an active infection again. Patients should not receive GAZYVA if they have active HBV liver disease. A patient’s doctor will do blood tests to check for HBV infection prior to treatment and will monitor the patient during and for several months following their treatment.
Progressive Multifocal Leukoencephalopathy (PML): a serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment, or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of the body, or blurred or lost vision.
Additional possible serious side effects of GAZYVA:
Patients must tell their doctor right away about any side effects they experience. GAZYVA can cause side effects that may become severe or life-threatening, including:
- Infusion Reactions: may occur during or within 24 hours of the infusion. The patient’s doctor should give the patient medicines before their treatment that may help to reduce the risk of an infusion reaction. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart, or chest pain.
- Tumor Lysis Syndrome (TLS):TLS is caused by a fast breakdown of cancer cells. TLS may cause an abnormal heartbeat or kidney failure requiring the need for dialysis treatment. The patient’s doctor may do blood tests to check the patient for TLS and give the patient medicines before their treatment to help prevent TLS. Symptoms of TLS may include nausea, vomiting, diarrhea and tiredness.
- Infections: Serious bacterial, fungal, and viral infections can occur during and following GAZYVA therapy. Symptoms may include fever and cough.
- Low blood cell counts: The patient’s blood cell counts may be monitored during treatment.
Most common side effects of GAZYVA
The most common side effects of GAZYVA are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, muscle and joint pain.
Before receiving GAZYVA, patients should talk to their doctor about :
Immunizations: Before receiving GAZYVA therapy, patients must tell their healthcare provider if they have recently received or scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines.
Pregnancy:Patients must tell their doctor if patients are pregnant or planning to become pregnant, or are breastfeeding. It is not known if GAZYVA may harm the patient’s unborn baby or pass into the patient’s breast milk. Women should use birth control while using GAZYVA and for 12 months after treatment.
Patients must tell their doctor about any side effect that bothers them or that does not go away.
These are not all of the possible side effects of GAZYVA. For more information, patients should ask their doctor or pharmacist.
GAZYVA is available by prescription only.
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please visit www.gazyva.com for the full Prescribing Information, including Boxed WARNING, for additional Important Safety Information.