Full Press Release Details
THOUSAND OAKS, Calif. , May 19, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced it will present new data from its oncology portfolio at the 21 st Congress of the European Hematology Association (EHA), June 9-12, 2016 , in Copenhagen . Key data to be presented include studies evaluating BLINCYTO ® (blinatumomab), Kyprolis ® (carfilzomib), Aranesp ® (darbepoetin alfa) and Nplate ® (romiplostim). Data from the BLINCYTO TOWER study will be presented during the Presidential Symposium on Friday, June 10 , and is recognized as a top abstract submitted to the Congress. This, along with other presentations, reinforces Amgen's commitment to serve patients with hematologic malignancies through the development of innovative and novel products.
"We are excited that the data from the TOWER study, which is the first randomized study of an immunotherapy to demonstrate overall survival benefit in adult patients with Ph-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, will be featured at the Presidential Symposium this year at EHA," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen. "This recognition along with other key data being presented validates our ongoing commitment to developing innovative therapies that have the potential to tackle unmet needs in complex-to-treat patient populations."
Key data include findings from clinical trials in acute lymphoblastic leukemia (ALL), multiple myeloma (MM), myelodysplastic syndrome (MDS) and immune thrombocytopenia (ITP):
BLINCYTO was granted conditional marketing authorization by the European Commission (EC) last November and is the first bispecific T cell engager (BiTE ® ) antibody construct approved in the European Union (EU) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL. Data from the comprehensive ALL development program to be presented will include:
Kyprolis was granted marketing authorization by the EC last November for use in combination treatment of patients with relapsed multiple myeloma. Data to be presented include:
Aranesp received initial EU approval within oncology in August 2002 and is indicated for the treatment of symptomatic anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. Data to be presented include:
Nplate, a thrombopoietin receptor agonist, was approved in the EU in February 2009 for the treatment of adult chronic-immune (idiopathic)-thrombocytopenic-purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Data to be presented include:
Abstracts are available and can be viewed on the EHA website at http://learningcenter.ehaweb.org/eha/#!*menu=16*browseby=2*sortby=1*media=3*label=9759 .
About BLINCYTO ® (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE ® ) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.
BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration, and is now approved in the U.S. for the treatment of Ph- relapsed or refractory B-cell precursor ALL. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
In November 2015 , BLINCYTO was granted conditional marketing authorization in the European Union for the treatment of adults with Ph- relapsed or refractory B-cell precursor ALL.
Important EU BLINCYTO ® (blinatumomab) Safety Information
This product is subject to additional monitoring in the EU. All suspected adverse reactions should be reported in accordance with the national reporting system.
The adverse reactions described in this section were identified in the pivotal clinical study (N=189).The most serious adverse reactions that may occur during blinatumomab treatment include: infections (31.7%), neurologic events (16.4%), neutropenia/febrile neutropenia (15.3%), cytokine release syndrome (0.5%), and tumor lysis syndrome (0.5%). The most common adverse reactions were: infusion-related reactions (67.2%), infections (63.0%), pyrexia (59.8%), headache (34.4%), febrile neutropenia (28%), peripheral edema (25.9%), nausea (24.3%), hypokalaemia (23.8%), constipation (20.6%), anaemia (20.1%), cough (18.5%), diarrhea (18.0%), tremor (17.5%), neutropenia (17.5%), abdominal pain (16.9%), insomnia (15.3%), fatigue (15.3%), and chills (15.3%).
Please refer to the Summary of Product Characteristics for full European prescribing information.
Important Safety Information Regarding BLINCYTO ® (blinatumomab) U.S. Indication
This safety information is specific to the current U.S. approved indication.
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
Contraindications
BLINCYTO ® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Warnings and Precautions
Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS occurred in patients receiving BLINCYTO ® . Infusion reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients for signs and symptoms of serious events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Interrupt or discontinue BLINCYTO ® as outlined in the Prescribing Information (PI).
Neurological Toxicities : Approximately 50% of patients receiving BLINCYTO ® in clinical trials experienced neurological toxicities. Severe, life-threatening, or fatal neurological toxicities occurred in approximately 15% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. The median time to onset of any neurological toxicity was 7 days. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO ® as outlined in the PI.
Infections: Approximately 25% of patients receiving BLINCYTO ® experienced serious infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO ® as needed.
Tumor Lysis Syndrome (TLS ): Life-threatening or fatal TLS has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on treatment hydration, should be used during BLINCYTO ® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO ® as needed to manage these events.
Neutropenia and Febrile Neutropenia , including life-threatening cases, have been observed. Monitor appropriate laboratory parameters during BLINCYTO ® infusion and interrupt BLINCYTO ® if prolonged neutropenia occurs.
Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO ® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO ® is being administered.
Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO ® treatment. The majority of these events were observed in the setting of CRS. The median time to onset was 15 days. Grade 3 or greater elevations in liver enzymes occurred in 6% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT), and TBILI prior to the start of and during BLINCYTO ® treatment. BLINCYTO ® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO ® especially in patients previously treated with cranial irradiation and anti-leukemic chemotherapy. Preparation and administration errors have occurred with BLINCYTO ® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
Adverse Reactions
The most commonly reported adverse reactions (≥ 20%) in clinical trials were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%), diarrhea (20%) and constipation (20%).
Serious adverse reactions were reported in 65% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, pneumonia, sepsis, neutropenia, device-related infection, tremor, encephalopathy, infection, overdose, confusion, Staphylococcal bacteremia, and headache.
U.S. Dosage and Administration Guidelines
BLINCYTO ® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm. It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).
Please see full U.S. Prescribing Information and medication guide for BLINCYTO ® at www.BLINCYTO.com .
About Kyprolis ® (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. 1 Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. 2 In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins. 2 The irreversibility of Kyprolis' binding has also been shown to offer a more sustained inhibition of the targeted enzymes. 3
Kyprolis is approved in the United States , Argentina , Israel , Kuwait , Mexico , Thailand , Colombia , Korea, Canada and the European Union. Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan . For more information, please visit www.kyprolis.com .
Important EU Kyprolis ® (carfilzomib) Safety Information
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy. The most serious side effects that may occur during Kyprolis treatment include: Cardiac toxicity, pulmonary toxicities, pulmonary hypertension, dyspnea, hypertension including hypertensive crises, acute renal failure, tumor lysis syndrome, infusion reactions, thrombocytopenia, hepatic toxicity, posterior reversible encephalopathy syndrome (PRES) and thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS). The most common side effects are anemia, fatigue, diarrhea, thrombocytopenia, nausea, pyrexia, dyspnea, respiratory tract infection, cough and peripheral edema.
Please refer to the Summary of Product Characteristics for full European prescribing information.
Important U.S. Safety Information Regarding Kyprolis ® (carfilzomib) for Injection
IMPORTANT SAFETY INFORMATION
Cardiac Toxicities
Acute Renal Failure
Tumor Lysis Syndrome
Pulmonary Toxicity
Pulmonary Hypertension
Venous Thrombosis
Infusion Reactions
Thrombocytopenia
Hepatic Toxicity and Hepatic Failure
Thrombotic Microangiopathy
Posterior Reversible Encephalopathy Syndrome (PRES)
Embryo-fetal Toxicity
ADVERSE REACTIONS
Please see full Prescribing Information at www.kyprolis.com .
About Aranesp ® (darbepoetin alfa) in the U.S.
Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Limitations of Use:
Aranesp has not been shown to improve quality of life, fatigue, or patient well-being.
Aranesp is not indicated for use:
Important EU Aranesp ® Safety Information
Aranesp is indicated for treatment of symptomatic anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Aranesp is contraindicated in patients with poorly controlled hypertension.
As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours. In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anemia associated with cancer.
In controlled clinical studies, use of Aranesp and other ESAs have shown:
In patients with solid tumours or lymphoproliferative malignancies, if Hb >12 g/dL (7.5 mmol/l), the dose should be reduced according to the instructions provided in the Summary of Product Characteristics to minimise the potential risk of thromboembolic events. Platelet counts and haemoglobin level should also be monitored at regular intervals.
Discontinue use after the end of chemotherapy.
Please refer to the Summary of Product Characteristics for full European prescribing information.
Important U.S. Safety Information for Aranesp ® (darbepoetin alfa)
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
Aranesp is contraindicated in patients with uncontrolled hypertension, pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs, or serious allergic reactions to Aranesp.
Use caution in patients with CKD and coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks. In controlled clinical trials of patients with cancer, Aranesp and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke. In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures. Control hypertension prior to initiating and during treatment with Aranesp.
Aranesp increases the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.