Full Press Release Details
THOUSAND OAKS, Calif. , Nov. 30, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced new data will be presented at the 58 th Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 3 – 6, 2016, in San Diego .
"The totality of data for our medicines to be presented at ASH underscores our commitment to helping patients with the toughest conditions through their journey," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen. "We look forward to sharing these studies and adding to the body of knowledge in acute lymphoblastic leukemia, multiple myeloma and other hematologic malignancies."
Amgen data to be presented at ASH include an oral presentation on results from a sub-analysis of the pivotal Phase 3 TOWER study evaluating the impact of BLINCYTO ® (blinatumomab) compared with standard of care chemotherapy on health-related quality of life in patients with relapsed or refractory Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (ALL):
Among the abstracts related to KYPROLIS ® (carfilzomib) is a new analysis of the pivotal Phase 3 ENDEAVOR trial that evaluates the cost-effectiveness of KYPROLIS compared to bortezomib when used in combination with dexamethasone in patients with relapsed or refractory multiple myeloma:
There will be an oral presentation on more than six years of data from an ongoing open-label extension study of Nplate ® (romiplostim) in children with immune thrombocytopenia (ITP):
Abstracts are currently available on the ASH website .
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, priority review and orphan drug designations by FDA, and is currently approved in the United States (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 (EU) for the treatment of adults with Ph- relapsed or refractory B-cell precursor ALL.
BLINCYTO ® U.S. Product Safety Information
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
Adverse Reactions
Dosage and Administration Guidelines
Please see full Prescribing Information, including Boxed WARNINGS 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. KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. 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.
KYPROLIS is approved in the U.S. for the following:
KYPROLIS is also approved in Argentina , Brazil , Canada , Colombia , the EU, Israel , Japan , Korea, Kuwait , Lebanon , Mexico , Thailand , Turkey , Russia , Switzerland , Qatar and the UAE. Additional regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.
For more U.S. information, please visit www.kyprolis.com .
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 Nplate ® (romiplostim) Nplate is approved in over 50 countries worldwide, including the U.S., EU, Canada, Australia, Russia, Mexico, Switzerland, Lichtenstein, Japan , Argentina , Israel , South Korea, Hong Kong and Chile. Nplate also has received orphan designation for chronic ITP in the U.S. (2003), the EU (2005) and other parts of the world.
Nplate is the first FDA-approved treatment specifically for adult chronic ITP.
In the U.S., Nplate is indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.
In the EU, Nplate is indicated for adult chronic-immune (idiopathic)-thrombocytopenic-purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Nplate was named as a recipient of the U.S. Prix Galien 2009 "Best Biotechnology Product" award and also received the 2009 Scrip Awards for "Best New Drug." Nplate has also been honored with numerous awards throughout the EU, including a 2010 Prix Galien in France in the category of "Drugs for Rare Diseases," and the 2011 Prix Galien in Germany in the category of "Specialist Care." In September 2010, Nplate was awarded the 2010 International Prix Galien Award, an award granted every two years which recognizes the "best of the best" selected from previous national Prix Galien award recipients.
For more information about Nplate, please visit www.Nplate.com .
Important U.S. Nplate ® Safety Information
Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia
Thrombotic/Thromboembolic Complications
Loss of Response to Nplate ®
Laboratory Monitoring
Adverse Reactions
Please see full U.S. Prescribing Information and Medication Guide at www.Nplate.com
About Amgen's Commitment to Oncology Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen's supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.
About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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The scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks Kristen Davis , 805-447-3008 (Media) Kristen Neese , 805-313-8267 (Media) Arvind Sood , 805-447-1060 (Investors)