Articles tagged with: Carfilzomib

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[ by | Jun 22, 2018 9:57 am | Comments Off ]
Einmal wöchentliches, hochdosiertes Kyprolis liefert tieferes Ansprechen und längere Remissionen als zweimal wöchentliches Kyprolis (ASCO & EHA 2018)

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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[ by | Jun 20, 2018 9:55 pm | One Comment ]
Once-Weekly High-Dose Kyprolis Yields Deeper Responses And Longer Remissions Than Twice-Weekly Kyprolis (ASCO & EHA 2018)

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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[ by | Jun 11, 2018 9:00 am | Comments Off ]
  • 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

FDA Approves Addition Of Positive Overall Survival Data From Phase 3 ASPIRE Trial To Kyprolis (Carfilzomib) Label 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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[ by | Jun 4, 2018 3:34 pm | 2 Comments ]
ASCO 2018 Update – Expert Perspectives On The Key Multiple Myeloma-Related Oral Presentations

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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[ by | Dec 28, 2017 11:05 am | Comments Off ]

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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[ by | Nov 10, 2016 8:34 am | Comments Off ]
Janssen Announces Clinical Trial Collaboration And Supply Agreement With Amgen To Evaluate Daratumumab (Darzalex) In Combination With Carfilzomib (Kyprolis)

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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[ by | Nov 10, 2016 8:33 am | Comments Off ]

Initial Phase 3 Registrational Study Planned in Relapsed or Refractory Multiple Myeloma Patients

Amgen Announces Collaboration With Janssen To Co-Fund Studies With Kyprolis (Carfilzomib) And Darzalex (Daratumumab) In Patients With Multiple Myeloma 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 …

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