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Press Release Issued: August 7, 2013, Philadelphia, PA & Mississauga, ON GSK to discontinue manufacture and sale of the BEXXAR® Therapeutic Regimen (tositumomab and iodine I 131 tositumomab) GlaxoSmithKline plc [LSE/NYSE: GSK] announced today it will discontinue the manufacture and sale of the BEXXAR® Therapeutic Regimen (tositumomab and iodine I 131 tositumomab) on February 20, 2014. BEXXAR is currently approved in the United States and Canada for the treatment of certain types of non-Hodgkin’s lymphoma (NHL). GSK is announcing its decision now to give treatment centers in the U.S. and Canada currently offering BEXXAR adequate time to consider and, if appropriate, transition to other therapies. The decision to discontinue BEXXAR involved a thoughtful and careful evaluation of patient needs and the clinical use of the therapy, which was approved for use in the U.S. in 2003 and in Canada in 2005. The use of BEXXAR has been extremely limited and is projected to continue to decline. Additionally, there are other treatment options available for patients with relapsed Non-Hodgkin’s Lymphoma. Over the next six months, GSK will continue to provide support services for patients and treatment centers. Physicians and patients with questions can call the GSK Response Center (GRC) at 1-888-825-5249 (U.S.) or 1-800-387-7374 (Canada). GSK’s commitment to the oncology community will continue through our efforts to develop and deliver other therapies to help address the unmet needs of patients living with cancer. About BEXXAR in Canada Important Safety Information - Canada Indication: BEXXAR® therapy (tositumomab and iodine I 131 tositumomab) is indicated for: the treatment of patients with CD20 positive relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, including patients with rituximab-refractory non-Hodgkin’s lymphoma. This product should be administered under the supervision of a qualified health professional who is appropriately qualified in the use of radioimmunotherapy and the management of patients with non- Hodgkin's lymphoma (NHL). Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available. Serious Warnings and Precautions Special requirements: BEXXAR® therapy (tositumomab and iodine I 131 tositumomab) contains a radioactive component and should be administered only by physicians and other health care professionals qualified by training in the safe use and handling of therapeutic radionuclides. Thyroid-blocking therapy must be initiated at least 24 hour before receiving the dosimetric dose and continued for 14 days after the therapeutic dose of BEXXAR® to decrease the risk of hypothyroidism (See WARNINGS AND PRECAUTIONS, Endocrine and Metabolism and DOSAGE AND ADMINISTRATION). Hypersensitivity reactions, including anaphylaxis: Serious hypersensitivity reactions, including some with fatal outcome, have been reported with BEXXAR®. Medications for the treatment of severe hypersensitivity reactions should be available for immediate use. Patients who develop severe hypersensitivity reactions should have infusions of BEXXAR® discontinued and receive medical attention (see ADVERSE REACTIONS, Infusional Toxicity and WARNINGS AND PRECAUTIONS, Immune). Prolonged and severe cytopenias: The majority of patients who received BEXXAR® experienced severe thrombocytopenia and neutropenia. BEXXAR® should not be administered to patients with > 25% lymphoma marrow involvement, platelet count < 100 x 109/L or neutrophil count < 1.5 x 109/L, and/or impaired bone marrow reserve (see WARNINGS AND PRECAUTIONS, Hematologic and ADVERSE REACTIONS). Pregnancy: BEXXAR® can cause fetal harm when administered to a pregnant woman. Warnings and Precautions General: BEXXAR® therapy (tositumomab and iodine I 131 tositumomab) is a biologic product with a radioactive component and should be administered only under the supervision of a health professional who is experienced in the use of radionuclides. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available. Radionuclide Precautions: Iodine I 131 tositumomab is radioactive. It may be received, used and administered only by authorized personnel. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organizations. As in the use of any other radioactive material, care should be taken to minimize radiation exposure to patients consistent with proper patient management, and to minimize radiation exposure to occupational workers. Advise patients of the risks of radiation exposure of household contacts, pregnant women, and small children and of the steps to be taken to reduce these risks. Contamination: The following measures should be taken by the patient for up to 2 weeks after receiving the radiopharmaceutical. Therapeutic dose: Avoidance of contact with infants, young children and pregnant women. Sleeping in a separate bed (separated by a distance of at least 2 to 3 meters). Maintain an appropriate distance of 2 meters from others. Travel alone in a private automobile if possible, otherwise maintain as great a distance as possible between patient and driver. Toilet should be used instead of urinal. Male patients should sit to use the toilet. Toilet should be flushed several times after use. Separate laundry and eating utensils and wash items separately. Carcinogenesis, Mutagenesis and Impairment of Fertility: No long-term animal studies have been performed to establish the carcinogenic or mutagenic potential of BEXXAR® or to determine its effects on fertility in males or females. However, radiation is a potential carcinogen and mutagen. Administration of BEXXAR® results in delivery of a significant radiation dose to the testes. The radiation dose to the ovaries has not been established. There have been no studies to evaluate whether administration of BEXXAR® causes hypogonadism, premature menopause, azoospermia, and/or mutagenic alterations to germ cells. There is a potential risk that BEXXAR® may cause toxic effects on the male and female gonads. Effective contraceptive methods should be used during treatment and for 12 months following administration of BEXXAR®. Secondary Malignancies: Although there were 995 patients in the investigator assessment, 10 patients were determined to have MDS/AML prior to BEXXAR® and were then excluded from the independent, masked pathology review. Based on an independent, masked pathology review, myelodysplastic syndrome (MDS) and/or acute leukemia developed in 32/985 (3.2%) patients after receiving BEXXAR®. This analysis yields an annualised incidence of 1.3% per year (95% CI: 0.9% - 1.8% per year). Most patients had extensive exposure to common alkylating agents and/or to topoisomerase II Page 2 inhibiting agents, which have all been documented as risk factors for the development of MDS and leukemia. It is unknown to what extent BEXXAR® plays a role in the development of MDS and/or leukemia in patients with NHL. Endocrine and Metabolism: Hypothyroidism: Use of BEXXAR® may result in hypothyroidism. Thyroid-blocking therapy must be initiated at least 24 hours before receiving the dosimetric dose and continue for 14 days after the therapeutic dose of BEXXAR® to decrease the risk of hypothyroidism. TSH levels should be monitored before and after BEXXAR®. After treatment, patients should be monitored for elevation of TSH and/or signs or symptoms of hypothyroidism every 6 months for the first 2 years, and annually thereafter. Hematologic: Prolonged and Severe Cytopenias (See Serious Warnings and Precautions): The most common adverse reactions associated with BEXXAR® were grade 3 or grade 4 cytopenias. These consisted primarily of grade 3 or 4 thrombocytopenia (53%) and grade 3 or 4 neutropenia (63%). The time to nadir was 4 to 7 weeks and the duration of cytopenias was approximately 30 days. Thrombocytopenia, neutropenia, and anemia persisted for more than 90 days following administration of BEXXAR® in 16 (7%), 15 (7%), and 12 (5%) patients respectively (this includes patients with transient recovery followed by recurrent cytopenia). Due to the variable nature in the onset of cytopenias, complete blood counts should be obtained weekly following BEXXAR® and should continue until levels recover. The safety of BEXXAR® has not been established in patients with > 25% lymphoma marrow involvement, platelet count < 100 x 109/L or neutrophil count < 1.5 x 109/L, therefore it should not be administered to these patients. Immune: Hypersensitivity Reactions Including Anaphylaxis (see Serious Warnings and Precautions): Severe hypersensitivity reactions may result in fatal outcomes during and following administration of BEXXAR®. Emergency supplies including medications for the treatment of hypersensitivity reactions, e.g., epinephrine, antihistamines, and corticosteroids, should be available for immediate use in the event of an allergic reaction during administration of BEXXAR®. Signs and symptoms of severe allergic reactions may include fever, rigors or chills, sweating, hypotension, dyspnea, bronchospasm, and nausea and have been reported during or within 48 hours of infusion. Patients who have received murine proteins should be screened for human anti-murine antibodies (HAMA). Patients who are positive for HAMA may be at increased risk of anaphylaxis and serious hypersensitivity reactions during administration of BEXXAR®. Immunization:
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