Http://www.gene.com/media/press-releases/14559/2013-11-01/fda-a

Genentech: Press Releases | FDA Approves Gazyva™ (Obinutuzumab) for People With P. Page 1 of 8 FDA Approves Gazyva™ (Obinutuzumab) for People With Previously Untreated Chronic Reduction in the Risk of Disease Worsening or Death When Combined with Chemotherapy Compared to Chemotherapy Alone • Gazyva is the First Medicine Approved with the South San Francisco, Calif. -- November 1, 2013 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Gazyva™ (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL). Gazyva (pronounced gah ZY vuh) is the first medicine approved with the FDA’s Breakthrough Therapy Designation and the fifth cancer medicine from Genentech approved by the FDA in the past three years.
http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinut. 11/6/2013 Genentech: Press Releases | FDA Approves Gazyva™ (Obinutuzumab) for People With P. Page 2 of 8 “Gazyva is an important new medicine for people with newly diagnosed chronic lymphocytic leukemia as it more than doubled the time people lived without their disease worsening compared to chlorambucil alone,” said Hal Barron, M.D., chief medical officer and head of Global Product Development. “We have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancers.” The FDA granted Gazyva Breakthrough Therapy Designation due to the significance of the positive progression-free survival (PFS) results from the Phase III CLL11 trial and the serious and life-threatening nature of CLL. Today’s FDA approval is based on the outcomes of the CLL11 trial. The trial showed that people who received Gazyva in combination with chlorambucil chemotherapy had significantly reduced risk of disease progression or death (HR=0.16; p<0.0001) and lived significantly longer without their disease getting worse compared to those who received chlorambucil alone (median PFS 23.0 months vs. 11.1 months). 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. Final data from the CLL11 trial investigating the direct comparison between Gazyva in combination with chlorambucil and Rituxan® (rituximab) in combination with chlorambucil (Stage 2) will be presented at the American Society of Hematology’s (ASH) 55th Annual Meeting in December 2013.
http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinut. 11/6/2013 Genentech: Press Releases | FDA Approves Gazyva™ (Obinutuzumab) for People With P. Page 3 of 8 Gazyva will be available to people in the United States within approximately two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking Gazyva through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (888) 249-4918. More information is also available at http://www.Genentech-Access.com.
Marketing applications have also been submitted to other regulatory authorities, including the European Medicines Agency (EMA). 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
http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinut. 11/6/2013 Genentech: Press Releases | FDA Approves Gazyva™ (Obinutuzumab) for People With P. Page 4 of 8 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.
Gazyva Indication Statement
http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinut. 11/6/2013 Genentech: Press Releases | FDA Approves Gazyva™ (Obinutuzumab) for People With P. Page 5 of 8 Gazyva™ (obinutuzumab) is a prescription medicine used with the chemotherapy chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
Important Safety Information
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. http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinut. 11/6/2013 Genentech: Press Releases | FDA Approves Gazyva™ (Obinutuzumab) for People With P. Page 6 of 8 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
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.
http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinut. 11/6/2013 Genentech: Press Releases | FDA Approves Gazyva™ (Obinutuzumab) for People With P. Page 7 of 8 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. http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinut. 11/6/2013 Genentech: Press Releases | FDA Approves Gazyva™ (Obinutuzumab) for People With P. Page 8 of 8 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. http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinut. 11/6/2013

Source: http://www.rhsadvisors.com/Obinutuzumab_Approval.pdf