Die Europäische Kommission hat Kyprolis (Carfilzomib) für die Behandlung des multiplen Myeloms zugelassen.

Die Zulassung bedeutet, dass Myelompatienten in Europa nun mit Kyprolis behandelt werden können, ohne sich in eine klinische Studie einschreiben zu müssen.

Obwohl Kyprolis in den Vereinigten Staaten vor mehr als drei Jahren zugelassen wurde, war die klinische Studie, die die Grundlage für diese Zulassung war, für eine europäische Zulassung nicht ausreichend. Zusätzliche Daten einer größeren klinischen Phase 3-Studie mussten für den europäischen Zulassungsantrag des Medikamentes gesammelt werden.

Die europäische Kyprolis-Zulassung gilt für den Einsatz des Medikamentes in Kombination …

The European Commission has approved Kyprolis (car­filz­o­mib) for the treat­ment of multiple myeloma.

The approval means that, for the first time, myeloma patients in Europe will be able to be treated with Kyprolis without having to enroll in a clinical trial.

Although Kyprolis was approved in the United States more than three years ago, the Phase 2 clinical trial that was the basis for that approval was not sufficient for a European approval. Additional data from a larger Phase 3 clinical trial had to be collected for …

First Irreversible Proteasome Inhibitor for Relapsed Multiple Myeloma Approved in the European UnionApproval Based on Data From Pivotal Phase 3 ASPIRE Trial Which Demonstrated Patients Treated With Kyprolis in Combination Lived Nearly Nine Months Longer Without Disease Progression Compared to Common Treatment Course

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the European Com­mis­sion (EC) granted market­ing authori­za­tion for Kyprolis^® (car­filz­o­mib) in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy. Kyprolis is the first irreversible pro­te­a­some inhibitor approved in the European Union (EU) for use in com­bi­na­tion treat­ment of patients with re­lapsed multiple myeloma.¹

"The approval of Kyprolis in com­bi­na­tion provides physicians and patients across Europe with an im­por­tant new treat­ment option for re­lapsed multiple myeloma, helping to address a real unmet need for this …

Pivotal Study Demonstrated Kyprolis® (Carfilzomib) in Combination With Standard of Care can Extend Time Patients Live Without Disease Progressing

BLINCYTO® (Blinatumomab) is First Bispecific T cell Engager (BiTE®) Antibody Construct to be Granted Positive CHMP Opinion

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions recommending market­ing authori­za­tion for:

Kyprolis^® (car­filz­o­mib) in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy, and

BLINCYTO^® (blina­tumo­mab) as a con­di­tional market­ing authori­za­tion for the treat­ment of adults with Philadelphia chromosome-negative (Ph-) re­lapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

"We are pleased to receive positive CHMP …

Application Based on Phase 3 Head-to-Head Trial Showing Superiority of Kyprolis and Dexamethasone Over Bortezomib Plus Dexamethasone

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Admin­istra­tion (FDA) has accepted for priority review the supple­mental New Drug Application (sNDA) of Kyprolis^® (car­filz­o­mib) for Injection for patients with re­lapsed multiple myeloma. The sNDA is designed to expand the current indi­ca­tion to in­clude Kyprolis in com­bi­na­tion with dex­a­meth­a­sone for patients who have received at least one prior ther­apy. The Prescription Drug User Fee Act (PDUFA) target action date is Jan. 22, 2016.

The FDA's acceptance of this new sNDA for Kyprolis follows the …

Hyderabad, India (Press Release) – Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) today announced that it has entered into a strategic col­lab­o­ration with Amgen – one of the world’s leading independent bio­technology com­pa­nies – to mar­ket and distribute three Amgen med­i­cines in India in the areas of on­col­ogy and cardiology. Under the terms of the col­lab­o­ration, Dr. Reddy’s shall per­form a full range of regu­la­tory and commercial services to seek approval and launch Kyprolis® (car­filz­o­mib), BLINCYTO® (blinatumomab) and Repatha™ (evolocumab) in India. The col­lab­o­ration leverages the capabilities of both com­pa­nies, combining three of Amgen’s inno­va­tive ther­a­pies …

The American Society of Clinical Oncology (ASCO) meeting in any given year is hit-or-miss as far as breaking research for multiple myeloma goes.

However, at ASCO 2015, there were no two views among myeloma experts. It was probably one of the most sig­nif­i­cant ASCO meetings as far as pre­senta­tions of abstracts that have the poten­tial to alter the land­scape of myeloma treat­ment in the near future.

There is no way to do justice to all the presentations at ASCO this year. However, I have tried to prepare a quiz to high­light …