• FDA action underscores poten­tial clin­i­cal benefit of dara­tu­mu­mab as a back­bone ther­apy in com­bi­na­tion with either a pro­te­a­some inhibitor (PI) or an immuno­modu­latory agent for patients who have received at least one prior ther­apy
• Marks the second Break­through Therapy Desig­na­tion for dara­tu­mu­mab

Raritan, NJ (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has granted a Break­through Therapy Desig­na­tion to the immuno­therapy dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with lena­lido­mide (an immuno­modu­la­tory agent) and dexa­metha­sone, or bor­tez­o­mib (a pro­te­a­some inhibitor [PI]) and dexa­metha­sone, for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy, Janssen Research & Development, LLC announced today. This marks the second time dara­tu­mu­mab has received a Break­through Therapy Desig­na­tion, which is in­tended to expedite the devel­op­ment and …

• Daratumumab receives Break­through Therapy Desig­na­tion in com­bi­na­tion with standard of care regi­mens for multiple myeloma patients who have received at least one prior line of ther­apy
• Potential for accelerated review
• Marks second Break­through Therapy Desig­na­tion for dara­tu­mu­mab

Copenhagen, Denmark (Press Release) — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Break­through Therapy Desig­na­tion for DARZALEX^® (dara­tu­mu­mab) injection in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy. Break­through Therapy Desig­nation is a pro­gram in­tended to expedite the devel­op­ment and review of drugs to treat serious or life-threatening diseases in cases where pre­lim­i­nary clin­i­cal …

Hallo Myelomwelt. Wie war Ihr Freitag bis jetzt?

Wir haben eine bunte Mischung aus fünf neuen Forschungsstudien über das multiple Myelom, die wir gern mit Ihnen heute besprechen möchten.

Drei der Studien sind über (vorklinische) Laborforschung, eine Forschungkategorie, die wir häufig erst am Ende unserer Berichte erörtern. Alle drei Forschungsstudien sind jedoch so interessant, dass wir sie zuerst besprechen werden.

Die erste Laborstudie betrifft Darzalex (Daratumumab) und die Kombinationsmöglichkeit mit einem experimentellen Antikrebsmedikament.

Die zweite Studie untersucht eine potenzielle neue virusbasierte Therapie für das multiple Myelom.

Die dritte Studie erweitert die vorhandene …

A new ther­apy providing an im­por­tant option for multiple myeloma patients who have received three or more prior lines of ther­apy

Toronto, Canada (Press Release) – Janssen Inc. announced today Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving DARZALEX™ (dara­tu­mu­mab) for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who are refractory to both a PI and an IMiD. Health Canada approved this prod­uct on the con­di­tion that Janssen Inc. carries out con­firmatory trials to verify the clin­i­cal benefit of DARZALEX™.¹

Multiple myeloma is an incurable blood cancer that …

Die Jahrestagung der amerikanischen Gesellschaft für Klinische Onkologie (ASCO) hat letzten Freitagmorgen begonnen und wird bis Dienstag, den 7. Juni, dauern.

Jeden Tag finden Vorträge über das multiple Myelom statt. Freitag wurden die meisten Vorträge mit neuen Forschungsergebnissen über das Myelom gehalten. Es gab neun Vorträge während einer einzelnen Nachmittagssitzung, die sich auf das multiple Myelom konzentrierten.

Außerdem gab es am Samstag, Sonntag und Montag Fortbildungssitzungen über das multiple Myelom. Darüber hinaus gab es am Sonntag eine Sitzung mit sogenannten late-braking abstracts (hochaktuellen Zusammenfassungen), die eine Präsentation über wichtige, neue Forschungsergebnisse über …

The 2016 annual meeting of the American Society of Clinical Oncology (ASCO) is now history, but there's still plenty of news to report from the meeting.

In this edition of the Beacon's ASCO multiple myeloma updates, the focus is on pre­sen­ta­tions that took place the last two days of the ASCO meet­ing – this past Monday and Tuesday – and which con­cerned poten­tial new multiple myeloma ther­a­pies.

There was a block of oral pre­sen­ta­tions related to poten­tial new myeloma ther­a­pies that took place Tuesday morning, and all those pre­sen­ta­tions are covered in this article. …

This year’s American Society of Clinical Oncology (ASCO) annual meeting began the morning of last Friday, and the meeting will run through Tues­day.

Multiple myeloma-related pre­sen­ta­tions are taking place every day of the meeting. Friday, how­ever, was the busiest day at the meeting in terms of oral pre­sen­ta­tions with new myeloma-related re­search. There were nine such pre­sen­ta­tions during a single afternoon session focused on multiple myeloma.

In addi­tion, there were myeloma-related education session pre­sen­ta­tions on Saturday, yesterday, and today. There also was a late-breaking ab­stract session yesterday (Sunday) with one pre­sen­ta­tion that …