• U.S. FDA grants Priority Review to dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone for re­lapsed multiple myeloma — February 17, 2017 PDUFA date
• U.S. FDA grants Standard Review to dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for re­lapsed or refractory multiple myeloma — June 17, 2017 PDUFA date

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Priority Review to the supple­mental Biologics License Application (sBLA) 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 have received at least one prior ther­apy. The sBLA was submitted by Genmab's licensing partner, Janssen Biotech, Inc. in August 2016. Priority Review …

Phase 3 data sup­porting sub­mission suggests poten­tial clin­i­cal benefit of dara­tu­mu­mab as a back­bone ther­apy in com­bi­na­tion with either a pro­te­a­some inhibitor (PI) or an immuno­modu­la­tory agent for re­lapsed multiple myeloma patients

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA), seeking to broaden the existing mar­ket­ing authori­sa­tion for the immuno­therapy DARZALEX®▼ (dara­tu­mu­mab) to in­clude treat­ment of adult patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. The expanded indi­ca­tion is based on dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide (an immuno­modu­la­tory agent) and dexa­meth­a­sone, or bor­tez­o­mib (a PI) and dexa­meth­a­sone.

Daratumumab is cur­rently approved by the European Com­mis­sion (EC) for mono­therapy of adult patients with …

• Application to broaden label for dara­tu­mu­mab for re­lapsed multiple myeloma submitted to EMA by Janssen
• Submission based on data from two Phase III studies, CASTOR and POLLUX
• Genmab to receive USD 10 million in mile­stone pay­ments from Janssen

Copenhagen, Denmark (Press Release) — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a variation to the Marketing Authori­za­tion to the European Medicines Agency (EMA) seeking to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy. The sub­mission of the appli­ca­tion triggers mile­stone pay­ments totaling USD 10 million to Genmab from Janssen. The mile­stone pay­ments were in­cluded in …

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 …