Supplemental Biologics License Application (sBLA) seeks second indi­ca­tion for dara­tu­mu­mab in combi­na­tion with standard of care regi­mens for patients with multiple myeloma who have received at least one prior ther­apy

Raritan, NJ (Press Release) – Janssen Biotech, Inc. announced today a supple­mental Biologics License Application (sBLA) for dara­tu­mu­mab (DARZALEX®) has been submitted to the U.S. Food and Drug Admin­is­tra­tion (FDA). The appli­ca­tion seeks to expand the current indi­ca­tion, using dara­tu­mu­mab 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. Dara­tu­mu­mab received Break­through Therapy Desig­na­tion from the FDA for this pending indi­ca­tion on July 25, 2016.

"Daratumumab has been …

• sBLA submitted to U.S. FDA for dara­tu­mu­mab for treat­ment of patients with re­lapsed multiple myeloma
• Submission based on data from two Phase III studies, CASTOR and POLLUX
• Genmab to receive USD 15 million in mile­stone pay­ments from Janssen

Copenhagen, Denmark (Press Release) — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc. has submitted a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who received at least one prior ther­apy. In July 2016, dara­tu­mu­mab was granted a Break­through Therapy Desig­na­tion (BTD) in this patient pop­u­la­tion. …

• 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 …