Full Press Release Details
THOUSAND OAKS, Calif. , April 30, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a label variation for KYPROLIS ® (carfilzomib) to include the final overall survival (OS) data from the Phase 3 ASPIRE trial. The ASPIRE trial demonstrated that the addition of KYPROLIS to lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 percent versus lenalidomide and dexamethasone alone (Rd) and extended OS by 7.9 months in patients with relapsed or refractory multiple myeloma (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 – 0.95; 1-sided p =0.0045).
KYPROLIS is approved in the European Union (EU) for use in combination with lenalidomide and dexamethasone or with dexamethasone alone (Kd) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The Kd regimen of twice-weekly KYPROLIS administered at 56 mg/m 2 and the KRd regimen of twice-weekly KYPROLIS administered at 27 mg/m 2 are the first and only therapeutic combinations to demonstrate consistently improved OS versus recent standards of care in two Phase 3 trials in relapsed or refractory multiple myeloma patients (Kd versus bortezomib and dexamethasone [Vd] and KRd versus Rd).
Since its approval in 2012, approximately 80,000 patients worldwide have received KYPROLIS. The KYPROLIS clinical program continues to focus on providing treatment options for physicians and patients for this frequently relapsing and difficult-to-treat cancer.
About ASPIRE The international, randomized Phase 3 ASPIRE (C A rfilzomib, Lenalidomide, and Dexametha S one versus Lenalidomide and Dexamethasone for the treatment of P at I ents with R elapsed Multiple My E loma) trial evaluated KYPROLIS in combination with lenalidomide and dexamethasone, versus lenalidomide and dexamethasone alone, in patients with relapsed or refractory multiple myeloma following treatment with one to three prior regimens. The primary endpoint of the trial was progression-free survival, defined as the time from treatment initiation to disease progression or death. Secondary endpoints included OS, overall response rate, duration of response, disease control rate, health-related quality of life and safety. Patients were randomized to receive KYPROLIS (20 mg/m 2 on days 1 and 2 of cycle one, escalating to 27 mg/m 2 on days 8, 9, 15 and 16 of cycle one and continuing on days 1, 2, 8, 9, 15 and 16 of subsequent cycles), in addition to a standard dosing schedule of lenalidomide (25 mg per day for 21 days on, seven days off) and low-dose dexamethasone (40 mg per week in four-week cycles), versus lenalidomide and low-dose dexamethasone alone. The study randomized 792 patients at sites in North America , Europe and Israel . The study results were published in the Journal of Clinical Oncology .
The safety data from ASPIRE was consistent with the known safety profile of KYPROLIS. The most common adverse events (greater than or equal to 20 percent) in the KYPROLIS arm were diarrhea, anemia, neutropenia, fatigue, upper respiratory tract infection, pyrexia, cough, hypokalemia, thrombocytopenia, muscle spasms, pneumonia, nasopharyngitis, nausea, constipation, insomnia and bronchitis.
About Multiple Myeloma Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. 1 It is a rare and very aggressive disease that accounts for approximately one percent of all cancers. 2,3 In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year and 24,000 patient deaths are reported on an annual basis. 4
About KYPROLIS ® (carfilzomib) Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. 5 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. 6 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. 5,6
KYPROLIS is approved in the EU for use in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three lines of therapy.
KYPROLIS is also approved in Argentina , Australia , Bahrain , Canada , Hong Kong , Israel , Japan , Kuwait , Lebanon , Macao , Mexico , Thailand , Colombia , S. Korea, Canada , Qatar , Switzerland , United Arab Emirates , Turkey , Russia , Brazil , India , Oman and the United States . Additional regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.
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, hemorrhage, hepatic toxicity, venous thromboembolism, posterior reversible encephalopathy syndrome (PRES) and thrombotic microangiopathy including 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 neutropenia.
Please refer to the Summary of Product Characteristics for full European prescribing information.
Important U.S. KYPROLIS ® (carfilzomib) Safety Information
In the United States , KYPROLIS ® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
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)
Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant - ineligible Patients
Embryo - fetal Toxicity
ADVERSE REACTIONS
Please see full US prescribing information at www.kyprolis.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.
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CONTACT: Amgen, Thousand Oaks Kristen Davis , 805-447-3008 (Media) Kristen Neese , 805-313-8267 (Media) Arvind Sood , 805-447-1060 (Investors)
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