About Chronic Lymphocytic Leukemia (CLL)CLL is one of the most common forms of blood cancer and in 2013, it is expected that there will be nearly 5,000 deaths from CLL in the United States. Most cases of CLL (95 percent) start in white blood cells called B-cells that have a protein called CD20 on their surface. About Gazyva Gazyva is a new monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body's immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen Idec. Gazyva is now approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL) and is additionally being investigated in a large clinical program, including multiple head-to-head Phase III studies compared to Rituxan in indolent non-Hodgkin’s lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL). Gazyva Efficacy In CLL The pivotal Phase III CLL11 trial, conducted in cooperation with the German CLL Study Group (GCLLSG), is a multicenter, open-label, randomized three-arm study investigating the efficacy and safety profile of either Gazyva plus chlorambucil or Rituxan plus chlorambucil compared to chlorambucil alone in 781 previously untreated people with CLL and co-existing medical conditions. The study showed that Gazyva demonstrated a statistically significant 84 percent reduction in the risk of disease worsening or death (PFS; HR=0.16, 95 percent CI 0.11-0.24, p<0.0001) when combined with chlorambucil compared to chlorambucil alone in people with previously untreated CLL and co-existing medical conditions. In the CLL11 study, no new safety signals were detected for Gazyva.
- Gazyva in combination with chlorambucil more than doubled the time people with newly diagnosed CLL lived without their disease getting worse (median PFS: 23.0 vs. 11.1 months).
- 75.9 percent of people responded to Gazyva plus chlorambucil (overall response rate, or ORR) compared to 32.1 percent with chlorambucil alone.
- More than a quarter of the people who received Gazyva in combination with chlorambucil achieved a complete response (CR: 27.8 percent vs. 0.9 percent).
- The most common Grade 3/4 adverse events for those who received Gazyva in combination with chlorambucil compared to chlorambucil alone were infusion-related reactions during the first infusion (21 percent vs. 0 percent [chlorambucil is an oral medicine]), low platelet count (thrombocytopenia, 11 percent vs. 3 percent) and low count of certain types of white blood cells (neutropenia, 34 percent vs. 16 percent) though this did not result in an increased rate of infections in the Gazyva arm.
Important Safety InformationPatients 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.
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 http://www.fda.gov/medwatch . Report side effects to Genentech at (888) 835-2555. Please visit http://www.gazyva.com for the full Prescribing Information, including Boxed WARNINGS, for additional Important Safety Information. About Genentech Access Solutions Genentech is committed to people having access to our medicines. Genentech Access Solutions is a team of more than 350 Genentech employees who help those who need our medicines. Our knowledgeable and experienced specialists can help patients and medical practices navigate the access and reimbursement process and provide assistance to eligible patients in the United States who do not have insurance coverage or who cannot afford their out-of-pocket co-pay costs. For more information, please visit http://www.Genentech-Access.com. About Genentech In Hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with cancers of the blood.
In addition to Gazyva, Genentech’s pipeline of potential hematology medicines includes two antibody-drug conjugates (anti-CD79b [RG7596] and anti-CD22 [RG7593]), a small molecule antagonist of MDM2 (RG7112) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (RG7601/GDC-0199/ABT-199).About Genentech Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.