Articles tagged with: Carfilzomib
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Zwischenergebnisse der klinischen Phase-3-Studie "ARROW" zeigen, dass einmal wöchentliches, hochdosiertes Kyprolis zu höheren Ansprechraten und längeren Remissionen bei Patienten mit rezidiviertem / refraktärem Myelom führt als zweimal wöchentliches, niedrigdosiertes Kyprolis (Carfilzomib).
Dr. Maria-Victoria Mateos präsentierte die Studienergebnisse Anfang des Monats auf der Jahrestagung der American Society of Clinical Oncology (ASCO) 2018 in Chicago und am vergangenen Wochenende auf dem Kongress 2018 der European Hematology Association in Stockholm. Zudem wurden die Studienergebnisse kürzlich in einer medizinischen Fachzeitschrift veröffentlicht (Referenz; auf Englisch).
Die Gesamtansprechrate auf die Medikamentenkombination Kyprolis-Dexamethason, die während der ARROW-Studie getestet …
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Once-weekly high-dose Kyprolis led to higher response rates and longer remissions in relapsed / refractory myeloma patients than twice-weekly, lower-dose Kyprolis (carfilzomib), interim results of the Phase 3 "ARROW" clinical trial show.
Dr. Maria-Victoria Mateos presented the trial results earlier this month at the 2018 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, and also last weekend at the 2018 congress of the European Hematology Association, held in Stockholm. In addition, the trial results were recently published in a medical journal (reference).
The overall response rate to the two-drug, …
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- Kyprolis, lenalidomide, and dexamethasone extended median overall survival in relapsed or refractory multiple myeloma patients to 48 months
- Kyprolis is the first and only treatment to demonstrate overall survival benefits in two Phase 3 studies in relapsed and refractory multiple myeloma
Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for KYPROLIS® (carfilzomib). Data added to the label showed that KYPROLIS, lenalidomide and dexamethasone (KRd) significantly reduced the risk of death by 21 percent and extended overall survival by 7.9 months versus lenalidomide and dexamethasone alone …
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This year’s American Society of Clinical Oncology (ASCO) annual meeting began last Friday and will run through tomorrow.
Multiple myeloma-related presentations have been taking place every day of the meeting. The main myeloma-related oral presentation session of the meeting, however, took place on Friday. Research summarized during oral presentation sessions usually is particularly important, either because the subject itself is important, or because the results are based on substantial amounts of evidence (for example, a sizable clinical trial).
Given the potential importance of the research results presented last Friday, The Beacon asked …
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Penn study finds proteasome inhibitor leads to higher than expected rates of cardiovascular adverse events
Philadelphia, PA (Press Release) – The proteasome inhibitor carfilzomib has taken on an increasing role in the treatment of multiple myeloma, but new research from the Abramson Cancer Center of the University of Pennsylvania shows the therapy comes with the risk of cardiovascular problems in a higher than expected percentage of patients. An analysis of past studies shows 18 percent of multiple myeloma patients receiving carfilzomib experience cardiovascular adverse events (CVAE) such as hypertension, heart failure, heart attacks, …
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Horsham, PA (Press Release) – Janssen Biotech, Inc. today announced that the company has entered into a master clinical trial collaboration and supply agreement with Onyx Pharmaceuticals, Inc., a wholly-owned subsidiary of Amgen, Inc., to evaluate the efficacy and safety of the first-in-class CD38-directed immunotherapy daratumumab (DARZALEX®) in combination with a proteasome inhibitor (PI) carfilzomib (KYPROLIS®) and dexamethasone. The agreement covers all potential opportunities for combining daratumumab and carfilzomib for the treatment of patients with cancer. Janssen licensed daratumumab from Genmab A/S and is responsible for all global development, marketing and manufacturing.1 …
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Initial Phase 3 Registrational Study Planned in Relapsed or Refractory Multiple Myeloma Patients
Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced a collaboration with Janssen Biotech, Inc. to evaluate the combination of Amgen's KYPROLIS® (carfilzomib) and Janssen's DARZALEX® (daratumumab) in multiple clinical studies in patients with multiple myeloma. Under the terms of the agreement, the companies may elect to supply drug only or supply drug and share development costs on a study-by-study basis.
The first study initiated as part of this agreement is a Phase 3 registrational trial evaluating KYPROLIS in combination with DARZALEX and dexamethasone compared to KYPROLIS and dexamethasone …