THOUSAND OAKS, Calif. and 观看比赛直播 SOUTH SAN FRANCISCO, Calif. (Dec. 3, 2014) - Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of BLINCYTO™ (blinatumomab) for FIFA 2026开球时间 the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued FIFA 2026开球时间 世界杯比赛时间 approval for this indication may be contingent upon verification of clinical benefit in subsequent trials. With this approval, 世界杯比赛时间 BLINCYTO 世界杯比赛时间 becomes the first FDA-approved bispecific CD19-directed CD3 T-cell engager (BiTE®) antibody construct product, and the first single-agent immunotherapy to be approved for the treatment of patients with Ph- relapsed or 观看比赛直播 refractory B-cell precursor ALL, 2026世界杯直播赛程 a rare FIFA 2026开球时间 FIFA 2026开球时间 世界杯比赛时间 世界杯比赛时间 2026世界杯直播赛程 and rapidly progressing cancer of the blood and FIFA 2026开球时间 bone marrow.1-3
“The FDA’s breakthrough therapy designation and FIFA 2026开球时间 accelerated approval of BLINCYTO underscores the critical need for new treatment options for patients with relapsed or refractory B-cell precursor ALL, who are 2026世界杯直播赛程 观看比赛直播 often young adults,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “BLINCYTO is the first clinical and regulatory validation of 世界杯比赛时间 the BiTE® platform, 世界杯比赛时间 2026世界杯直播赛程 2026世界杯直播赛程 世界杯比赛时间 a new and innovative approach that helps the body’s own immune system fight cancer.”
The BLINCYTO approval is based on results of Amgen’s ‘211 trial, a Phase 2, multicenter, single-arm open-label study. Eligible patients were ≥ 18 years of age with Ph- relapsed or refractory FIFA 2026开球时间 B-cell precursor FIFA 2026开球时间 观看比赛直播 FIFA 2026开球时间 ALL. Relapsed or refractory was defined as relapsed with first remission duration of < 12 months in the first salvage, or relapsed or 2026世界杯直播赛程 refractory FIFA 2026开球时间 after first salvage therapy, or relapsed 世界杯比赛时间 within 12 months FIFA 2026开球时间 世界杯比赛时间 of allogeneic hematopoietic stem cell transplantation (HSCT), and had >= 10 percent blasts in bone marrow. Of the 185 patients evaluated in the trial, 41.6 percent (77/185; 95 percent CI: 34.4-49.1) 世界杯比赛时间 achieved 世界杯比赛时间 FIFA 2026开球时间 观看比赛直播 complete remission or complete remission with partial FIFA 2026开球时间 hematologic recovery (CR/CRh*) within two cycles of treatment with BLINCYTO, which was the primary endpoint of the 2026世界杯直播赛程 study. The majority of responses (81 世界杯比赛时间 percent [62/77]) occurred within the first FIFA 2026开球时间 cycle of 世界杯比赛时间 treatment. Among patients who achieved CR/CRh*, 39 percent (30/77) went on to HSCT, and 75.3 percent (58/77 95 percent CI: 64.2-84.4) achieved minimal 世界杯比赛时间 FIFA 2026开球时间 residual disease (MRD) response, a measure of eradication of residual disease at the molecular level.
“The approval of BLINCYTO represents a significant milestone in immunotherapy research, providing clinicians the opportunity to offer a new single-agent therapy to patients fighting this 世界杯比赛时间 highly aggressive cancer 2026世界杯直播赛程 世界杯比赛时间 with previously limited options,” said Anthony S. Stein, M.D., clinical professor, Hematology/Oncology at City of Hope.
BLINCYTO has a BOXED WARNING in its product label regarding Cytokine Release Syndrome (CRS) and Neurological Toxicities.
Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt 世界杯比赛时间 or discontinune BLINCYTO as recommended. Neurological toxicities, which may be severe, 2026世界杯直播赛程 世界杯比赛时间 世界杯比赛时间 FIFA 2026开球时间 life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended.
BLINCYTO is contraindicated to patients with known hypersensitivity to blinatumomab FIFA 2026开球时间 or to any component of the product formulation.
Monitor patients for signs and symptoms of infection and treat appropriately.
Advise patients to refrain from driving and 世界杯比赛时间 engaging in hazardous occupations or activities such as driving, operating heavy or potentially dangerous 世界杯比赛时间 machinery while BLINCYTO is being 观看比赛直播 administered.
It is important to strictly follow 观看比赛直播 instructions for preparation (including 观看比赛直播 admixing) and administration to prevent overdose and underdose.
The most common adverse reactions (≥ 20 percent) were pyrexia (62 percent), headache (36 percent), peripheral edema 世界杯比赛时间 (25 percent), febrile neutropenia (25 percent), nausea (25 percent), hypokalaemia (23 percent), 世界杯比赛时间 世界杯比赛时间 rash (21 percent), tremor (20 2026世界杯直播赛程 percent) and constipation (20 percent). Serious adverse 世界杯比赛时间 reactions were reported in 65 percent of patients. The FIFA 2026开球时间 most common serious adverse 观看比赛直播 reactions (≥ 2 percent) included febrile 世界杯比赛时间 neutropenia, pyrexia, pneumonia, sepsis, neutropenia, device-related infection, tremor, 观看比赛直播 encephalopathy, infection, overdose, confusion, Staphylococcal bacteremia and headache.
The FDA has also FIFA 2026开球时间 approved 观看比赛直播 a risk evaluation and 2026世界杯直播赛程 mitigation strategy (REMS) for BLINCYTO. The purpose of 世界杯比赛时间 the BLINCYTO REMS is to inform healthcare providers of the serious risks of CRS, neurological FIFA 2026开球时间 toxicities, 世界杯比赛时间 and preparation and administration errors. Additional information about the BLINCYTO REMS program can be found at 2026世界杯直播赛程 http://www.blincytorems.com/.
Please contact Amgen Medinfo at 800-77-AMGEN 2026世界杯直播赛程 (800-772-6436) regarding BLINCYTO availability.
Amgen and its subsidiary Onyx Pharmaceuticals, Inc., 世界杯比赛时间 which will 2026世界杯直播赛程 commercialize 世界杯比赛时间 BLINCYTO in the U.S., have announced the availability of Onyx Pharmaceuticals 360™ (Onyx 360), to patients receiving BLINCYTO in 世界杯比赛时间 FIFA 2026开球时间 the U.S. Onyx 360 is a 世界杯比赛时间 comprehensive patient and caregiver support and services program designed to help patients navigate 世界杯比赛时间 the treatment journey, including reimbursement and payment support, treatment support 观看比赛直播 世界杯比赛时间 观看比赛直播 FIFA 2026开球时间 FIFA 2026开球时间 and referrals to third-party organizations for day-to-day needs and emotional support. Dedicated Oncology Nurse Advocates 2026世界杯直播赛程 are available Monday through Friday from 9 a.m. to 8 p.m. Eastern Standard Time at 观看比赛直播 FIFA 2026开球时间 2026世界杯直播赛程 FIFA 2026开球时间 1-855-ONYX-360 (1-855-669-9360) to assist patients, caregivers and healthcare providers.
Patients diagnosed with adult ALL are often young adults, with a median age at diagnosis of 34-39.4 In adult patients with relapsed or refractory ALL, median overall survival is just three to five months. 观看比赛直播 2026世界杯直播赛程 5
About BLINCYTO™ (blinatumomab)
BLINCYTO is the first BiTE® antibody construct and the first single-agent immunotherapy to be approved by the U.S. Food and Drug Administration (FDA).3 FIFA 2026开球时间 FIFA 2026开球时间 观看比赛直播 BLINCYTO was granted breakthrough therapy and 2026世界杯直播赛程 priority review designations by the FDA, and is now approved in 2026世界杯直播赛程 the U.S. for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell
世界杯比赛时间 precursor acute lymphoblastic leukemia (ALL).
About BiTE® Technology
Bispecific T cell engager (BiTE®) antibody constructs are a type of immunotherapy 世界杯比赛时间 being investigated for fighting cancer by helping the body’s immune
2026世界杯直播赛程 FIFA 2026开球时间 世界杯比赛时间 FIFA 2026开球时间 system to detect FIFA 2026开球时间 and target 世界杯比赛时间 malignant cells. 观看比赛直播 The modified antibodies are designed to engage two different targets 世界杯比赛时间 simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing
FIFA 2026开球时间 FIFA 2026开球时间 观看比赛直播 other cells perceived as 世界杯比赛时间 threats) to cancer cells. BiTE® 观看比赛直播 antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins
2026世界杯直播赛程 2026世界杯直播赛程 and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit
世界杯比赛时间 2026世界杯直播赛程 观看比赛直播 观看比赛直播 http://www.biteantibodies.com/.
Important U.S. Product Information BLINCYTO is indicated FIFA 2026开球时间 for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated FIFA 2026开球时间 approval. Continued approval for 观看比赛直播 this indication may be contingent upon verification of clinical benefit in subsequent trials.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
Contraindications
BLINCYTO™ 世界杯比赛时间 is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Warnings and Precautions
Adverse Events
Dosage and Administration Guidelines
Please FIFA 2026开球时间 see full 观看比赛直播 Prescribing Information and medication guide for BLINCYTO at http://www.blincyto.com/.
About Amgen
Amgen is committed to unlocking the FIFA 2026开球时间 potential of biology for patients 观看比赛直播 suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative
世界杯比赛时间 2026世界杯直播赛程 FIFA 2026开球时间 世界杯比赛时间 human therapeutics. This approach begins by FIFA 2026开球时间 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 biologics manufacturing expertise FIFA 2026开球时间 世界杯比赛时间 to strive for solutions that improve health outcomes and dramatically improve people’s lives. FIFA 2026开球时间 FIFA 2026开球时间 世界杯比赛时间 观看比赛直播 A FIFA 2026开球时间 世界杯比赛时间 biotechnology pioneer since 1980, Amgen 世界杯比赛时间 has grown to be the 世界杯比赛时间 world’s largest independent biotechnology company, has reached 世界杯比赛时间 millions of 2026世界杯直播赛程 FIFA 2026开球时间 patients around the world and is developing a pipeline FIFA 2026开球时间 of medicines with breakaway potential.
For more information, FIFA 2026开球时间 visit http://www.amgen.com/ and follow us on http://www.twitter.com/amgen.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc., an Amgen FIFA 2026开球时间 subsidiary, 世界杯比赛时间 is a global biopharmaceutical company engaged in the development
FIFA 2026开球时间 世界杯比赛时间 观看比赛直播 and commercialization of innovative therapies for improving the lives of people 观看比赛直播 with cancer. The FIFA 2026开球时间 company is focused on developing novel medicines that target key molecular pathways. For more
FIFA 2026开球时间 information about Onyx, visit the FIFA 观看比赛直播 2026开球时间 company's website at www.onyx.com. 2026世界杯直播赛程 Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.
Forward-Looking Statements
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FIFA 2026开球时间 世界杯比赛时间 or us) and FIFA 2026开球时间 are subject to 观看比赛直播 a number of risks, uncertainties and assumptions that could cause actual results to 2026世界杯直播赛程 differ materially from those described. All statements, other than statements
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世界杯比赛时间 FIFA 2026开球时间 FIFA 2026开球时间 expected legal, arbitration, political, 2026世界杯直播赛程 regulatory or clinical results or practices, customer and 观看比赛直播 prescriber patterns or practices, reimbursement activities and outcomes and other such estimates
FIFA 2026开球时间 and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission 观看比赛直播 世界杯比赛时间 (SEC)
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世界杯比赛时间 2026世界杯直播赛程 FIFA 2026开球时间 观看比赛直播 FIFA 2026开球时间 recent Forms 观看比赛直播 10-K, 10-Q and 8-K for FIFA 2026开球时间 additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of
世界杯比赛时间 FIFA 2026开球时间 Dec. 3, 2014, and expressly disclaims any duty to update information contained in this 2026世界杯直播赛程 news release.
No forward-looking statement can be guaranteed and actual results may differ FIFA 2026开球时间 materially from those we project. Discovery or identification of new product FIFA 2026开球时间 candidates or development of new indications 世界杯比赛时间 2026世界杯直播赛程 观看比赛直播 世界杯比赛时间 世界杯比赛时间 for existing products cannot be guaranteed and movement from 2026世界杯直播赛程 concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development FIFA 2026开球时间 FIFA 2026开球时间 世界杯比赛时间 of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance 世界杯比赛时间 of product candidates 2026世界杯直播赛程 in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal FIFA 2026开球时间 models. The length of time that it takes 2026世界杯直播赛程 2026世界杯直播赛程 for us 世界杯比赛时间 and our partners to complete clinical trials 2026世界杯直播赛程 and obtain regulatory approval FIFA 2026开球时间 for product FIFA 2026开球时间 marketing has in the past varied and we expect similar variability in the future. We develop FIFA 2026开球时间 FIFA 2026开球时间 FIFA 2026开球时间 product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are 2026世界杯直播赛程 derived from relationships may be subject to disputes between FIFA 2026开球时间 FIFA 2026开球时间 the parties or may prove to be not as effective or as safe as we may have believed at the 世界杯比赛时间 time of entering into 观看比赛直播 such relationship. Also, we or others could identify safety, side effects or 世界杯比赛时间 FIFA 2026开球时间 2026世界杯直播赛程 manufacturing problems with our products after they are on the market. Our business may be impacted by government FIFA 2026开球时间 investigations, litigation and product liability claims. If we fail to meet 观看比赛直播 2026世界杯直播赛程 FIFA 2026开球时间 the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant 观看比赛直播 2026世界杯直播赛程 世界杯比赛时间 portion of our manufacturing capacity for the 2026世界杯直播赛程 supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product 观看比赛直播 2026世界杯直播赛程 FIFA 2026开球时间 观看比赛直播 世界杯比赛时间 candidate development.
In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, 世界杯比赛时间 private 观看比赛直播 世界杯比赛时间 insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and 2026世界杯直播赛程 domestic and international trends toward managed care and FIFA 2026开球时间 healthcare 观看比赛直播 观看比赛直播 FIFA 2026开球时间 世界杯比赛时间 cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, 世界杯比赛时间 世界杯比赛时间 FIFA 2026开球时间 usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. FIFA 2026开球时间 世界杯比赛时间 We believe that some of FIFA 2026开球时间 our newer products, product candidates or new indications for existing products, may face competition when 观看比赛直播 and as they are approved and marketed. Our products may 世界杯比赛时间 FIFA 2026开球时间 观看比赛直播 观看比赛直播 FIFA 2026开球时间 compete against products that have lower 观看比赛直播 prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, 世界杯比赛时间 观看比赛直播 FIFA 2026开球时间 FIFA 2026开球时间 while we and our partners routinely obtain patents for our 世界杯比赛时间 and their products and technology, the protection of our 观看比赛直播 products offered by patents and patent applications may be challenged, 观看比赛直播 观看比赛直播 invalidated or FIFA 2026开球时间 circumvented by our or 2026世界杯直播赛程 our partners’ competitors and there can be no guarantee of our or our partners’ ability to obtain or maintain patent protection for our products or product 世界杯比赛时间 世界杯比赛时间 FIFA 2026开球时间 candidates. We 世界杯比赛时间 cannot guarantee that we will be able to 世界杯比赛时间 produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected 观看比赛直播 世界杯比赛时间 by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product 世界杯比赛时间 2026世界杯直播赛程 similar to one of our products that implicate an entire class of products could have 世界杯比赛时间 a material adverse effect on sales of the affected products and on our business and results of operations. 世界杯比赛时间 世界杯比赛时间 世界杯比赛时间 2026世界杯直播赛程 Our efforts to integrate the operations of companies we have acquired FIFA 2026开球时间 may not be successful. Cost savings initiatives may result in us incurring impairment or other related charges on 观看比赛直播 our FIFA 2026开球时间 世界杯比赛时间 世界杯比赛时间 2026世界杯直播赛程 观看比赛直播 2026世界杯直播赛程 世界杯比赛时间 世界杯比赛时间 assets. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our recently announced restructuring plans. Our business performance 世界杯比赛时间 世界杯比赛时间 2026世界杯直播赛程 FIFA 2026开球时间 could affect or limit the ability of FIFA 2026开球时间 our Board of Directors to 世界杯比赛时间 declare a dividend or our ability to pay a dividend or repurchase common stock.
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References
1. Mayo Clinic. “Acute lymphocytic leukemia.” Available at: http://www.mayoclinic.com/health/acute-lymphocytic-leukemia/DS00558.
世界杯比赛时间 Accessed on October 30, 2014.
2. BLINCYTO™ Draft US Prescribing Information.>
3. NCCN Clinical Practice Guidelines in Oncology (NCCN 观看比赛直播 Guidelines®): Acute Lymphoblastic
FIFA 2026开球时间 FIFA 2026开球时间 Leukemia. Version 1.2014. Available at: https://www.nccn.org/store/login/login.aspx?ReturnURL=http://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed on 2026世界杯直播赛程 November 24, 2014.
4. Seer 2014 data.
2026世界杯直播赛程 FIFA 2026开球时间 2026世界杯直播赛程 FIFA 2026开球时间 FIFA 2026开球时间 Available at: http://seer.cancer.gov/statfacts/html/leuks.html. Accessed on November
世界杯比赛时间 FIFA 2026开球时间 FIFA 2026开球时间 世界杯比赛时间 世界杯比赛时间 世界杯比赛时间 2026世界杯直播赛程 世界杯比赛时间 4, 2014. FIFA 2026开球时间
5. Advani 世界杯比赛时间 A.S. New immune strategies 世界杯比赛时间 for the treatment of acute lymphoblastic leukemia: Antibodies and chimeric 世界杯比赛时间 antigen receptors. Hematology Am Soc Hematol Educ Program. 2013;2013:131-7.
观看比赛直播 Retrieved from: http://asheducationbook.hematologylibrary.org/content/2013/1/131.long.
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