Full Press Release Details
THOUSAND OAKS, Calif. , June 19, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced that the European Commission (EC) has granted a full marketing authorization for BLINCYTO ® (blinatumomab) based on the overall survival (OS) data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
"BLINCYTO is the first single agent immunotherapy to demonstrate superior overall survival benefit over standard of care," said David M. Reese , M.D., senior vice president of Translational Sciences and Oncology at Amgen. "For decades, overall survival has been the gold standard for assessing the efficacy of treatments for blood cancers. The near doubling of median overall survival versus standard of care seen in the TOWER study is groundbreaking and reinforces BLINCYTO as a highly effective ALL therapy, providing physicians with a much needed, efficacious treatment option, potentially offering patients the chance to live longer."
BLINCYTO is the first-and-only bispecific CD19-directed CD3 T cell engager (BiTE ® ) immunotherapy construct approved globally. It is also the first bispecific immunotherapy from Amgen's BiTE ® platform, an innovative approach that helps the body's immune system target cancer cells.
In the TOWER study, BLINCYTO demonstrated a superior improvement in median OS over standard of care (SOC) chemotherapy. Median OS was 7.7 months (95 percent CI: 5.6, 9.6) for BLINCYTO versus four months (95 percent CI: 2.9, 5.3) for SOC (HR for death=0.71; p =0.012). For patients treated in first salvage, the median OS was 11.1 months for BLINCYTO versus 5.3 months for SOC (HR=0.6, 95 percent CI: 0.39, 0.91). Safety results among subjects who received BLINCYTO were comparable to those seen in the previous Phase 2 studies of BLINCYTO in adult patients with Ph- relapsed or refractory B-cell precursor ALL.
Approval via the centralized procedure allows for obtaining a marketing authorization from the EC, which is valid in all European Union (EU) and European Economic Area (EEA)-European Free Trade Association (EFTA) states ( Norway , Iceland and Liechtenstein ).
About TOWER The TOWER study was a Phase 3, randomized, active-controlled, open-label study investigating the efficacy of BLINCYTO versus SOC chemotherapy in 405 adult patients with Ph- relapsed or refractory B-cell precursor ALL. The study enrolled a difficult-to-treat patient population which included patients at several states of relapse. In the BLINCYTO arm, this included 35 percent of patients that had relapsed post-allogenic hematopoietic stem cell transplant (alloHSCT), and excluded those with late first relapse (≥12 months after initial remission). Patients were randomized in a 2:1 ratio to receive BLINCYTO (n=271) or treatment with investigator choice of SOC chemotherapy (n=134). The determination of efficacy was based on OS. Per the recommendation of an independent data monitoring committee, Amgen ended the study early for evidence of superior efficacy in the BLINCYTO arm versus SOC chemotherapy. These results were published in The New England Journal of Medicine .
About Adult ALL in Europe ALL is a rare and rapidly progressing cancer of the blood and bone marrow. 1,2 The incidence of adult ALL in European countries is generally between 0.6 to 0.9 per 100,000 persons per year. 3 In adult ALL, approximately 75 percent is B-cell precursor ALL, of which 75-80 percent is Ph- and roughly half will be refractory to treatment or experience relapse. 3 Thus, with a population projection of 416 million adults in the EU, 4 it is estimated that the incidence of adult Ph- relapsed or refractory B-cell precursor ALL in the EU is approximately 900 patients per year. 5
About BLINCYTO ® (blinatumomab) BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE ® ) immunotherapy construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of effector T cells. BLINCYTO was granted breakthrough therapy and priority review designations by the FDA in 2014, and carries full approval in the U.S. for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. In the U.S., BLINCYTO is also approved under accelerated approval for the treatment of adults and children with B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival (RFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
In 2015, BLINCYTO was granted conditional marketing authorization in the EU for the treatment of adults with Ph- relapsed or refractory B-cell precursor ALL.
About BiTE ® Technology Bispecific T cell engager (BiTE ® ) antibody constructs are a novel immuno-oncology technology that can theoretically be engineered to target any surface antigen expressed by any type of cancer. The modified antibodies are designed to kill malignant cells using the patient's own immune system, by bridging T cells to tumor cells. BiTE ® antibody constructs connect the T cells to the targeted cell, with the intent of allowing T cells to inject toxins which trigger cancer cell death (apoptosis). Amgen is developing BiTE ® antibody constructs to uniquely target numerous hematologic malignancies and solid tumors.
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 randomized Phase 3 clinical trial (n=267) and in the single-arm Phase 2 study (n=189) in adults with Ph- relapsed or refractory B-precursor ALL who received BLINCYTO ® . The most serious adverse reactions that may occur during blinatumomab treatment include: infections (29.6%), neutropenia/febrile neutropenia (11.6%), neurologic events (11.6%), cytokine release syndrome (2.4%), and tumour lysis syndrome (0.9%). The most common adverse reactions were: infections (63.6%), pyrexia (60.1%), infusion-related reactions (32.0%), headache (31.1%), febrile neutropenia (25.7%), anaemia (24.8%), oedema (24.1%), neutropenia (22.1%), thrombocytopenia (20.4%), increased liver enzymes (16.7%), cough (16.2%), and rash (16.0%).
Please refer to the Summary of Product Characteristics for full European prescribing information.
Important Safety Information Regarding BLINCYTO ® (blinatumomab) U.S. 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
Adverse Reactions
Dosage and Administration Guidelines
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO ® .
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.
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