Application sup­ported by the Phase 3 MAIA study for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eligible for au­tol­o­gous stem cell trans­plant

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA) for DARZALEX®▼ (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

“Today’s sub­mission brings us one step closer to our goal of im­prov­ing treat­ment out­comes for people newly diag­nosed with multiple myeloma,” said José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and …

• Type II variation appli­ca­tion submitted to the EMA for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed multiple myeloma patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III MAIA study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation appli­ca­tion to the European Medicines Agency (EMA). The appli­ca­tion seeks to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude use in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for newly diag­nosed multiple myeloma patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The sub­mission is based on data from the Phase III …

Shanghai, China (Press Release) – I-Mab Bio­pharma (I-Mab), a China-based clin­i­cal stage bio­pharma­ceu­tical com­pany ex­clu­sively focused on the devel­op­ment of inno­va­tive biologics in immuno-oncology and auto­immune dis­eases, and German biopharma com­pany MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;NASDAQ: MOR), to­day an­nounced that the first patient dosing (FPD) has been achieved in a phase 2 multi-center clin­i­cal study in Taiwan to eval­u­ate an inves­ti­ga­tional human CD38 anti­body TJ202 / MOR202 in patients with re­lapsed or re­frac­tory multiple myeloma. TJ202 / MOR202 is an anti­body devel­oped by MorphoSys AG. I-Mab owns the ex­clu­sive …

Application sup­ported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot pro­gram

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

The sBLA, based upon data from the Phase 3 MAIA (MMY3008) clin­i­cal study, is being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot pro­gram, which for …

• Phase III COLUMBA study com­par­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab to the in­tra­venous for­mu­la­tion in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma met both co-primary end­points
• Results show that dara­tu­mu­mab admin­istered sub­cu­tane­ously was non-inferior in ef­fi­cacy and phar­ma­co­ki­netics as com­pared to dara­tu­mu­mab admin­istered in­tra­venously
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings in sup­port of bringing con­ve­nience of sub­cu­tane­ous dara­tu­mu­mab op­tion to patients

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) an­nounced to­day top­line re­­sults from the Phase III COLUMBA study (MMY3012) of sub­cu­tane­ous (SC) versus in­tra­venous (IV) dara­tu­mu­mab for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. The re­­sults showed that SC admin­istra­tion of dara­tu­mu­mab co-formulated with recombinant human hyal­uron­i­dase PH20 is non-inferior to IV admin­istra­tion of dara­tu­mu­mab with regard to the co-primary end points of over­all re­sponse rate (ORR) and Maximum Trough con­cen­tra­tion (C_trough) of dara­tu­mu­mab on day 1 of …

Revised prod­uct label allows for new admin­istra­tion option

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved a split-dosing regi­men for DARZALEX® (dara­tu­mu­mab), providing health­care professionals and patients with multiple myeloma an option to split the first in­fusion over two consecutive days.¹ The U.S. FDA approval is based on data from the Phase 1b EQUULEUS (MMY1001) clin­i­cal study, which dem­onstrated DARZALEX phar­ma­co­ki­netic (PK) con­cen­tra­tions were com­parable at the end of weekly dosing, re­gard­less of whether the first dose was admin­istered as a split in­fusion …

• DARZALEX split dosing regi­men approved by U.S. FDA
• Provides health­care professionals with option to split first DARZALEX in­fusion over two consecutive days
• Approval sup­ported by data from EQUULEUS (MMY1001) clin­i­cal trial

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved a split dosing regi­men for DARZALEX® (dara­tu­mu­mab). The approval will be in­cluded in an update to the Prescribing Infor­ma­tion in order to provide health­care professionals the option to split the first in­fusion of DARZALEX over two consecutive days. The supple­mental Biologics License Application (sBLA) was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., in July, 2018. The split dosing …