• Supplemental new drug appli­ca­tion submitted in Japan for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III ALCYONE study
• Genmab to receive USD 2 million mile­stone pay­ment from Janssen

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharma­ceu­tical K.K. has submitted a supple­mental new drug appli­ca­tion (sNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan, for the use of dara­tu­mu­mab (DAR­ZALEX®) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The appli­ca­tion will receive a priority review. The sub­mission of the appli­ca­tion triggers …

• CHMP issued pos­i­tive opinion on split dosing regi­men for DARZALEX
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion sup­ported by data from EQUULEUS (MMY1001) clin­i­cal trial

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a pos­i­tive opinion rec­om­mending updating the existing mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in the European Union. The recom­men­da­tion is to update the Summary of Product Characteristics in order to provide health care professionals the option to split the first in­fusion of DARZALEX over two consecutive days. The Type II variation …

• SEA-BCMA is a Novel Empowered Antibody Targeting BCMA for Multiple Myeloma
• Adds to Seattle Genetics’ Robust Clinical-Stage Development Pipeline across Multiple Hematologic and Solid Tumors

Bothell, WA (Press Release) – Seattle Genetics, Inc. (Nasdaq:SGEN) announced today dosing of the first patient in a phase 1 clin­i­cal trial eval­u­ating the safety and tolerability of SEA-BCMA for patients with re­lapsed or refractory multiple myeloma (MM). SEA-BCMA is an inves­ti­ga­tional anti­body empowered using Seattle Genetics’ pro­pri­e­tary Sugar Engineered Antibody (SEA) tech­nology designed to en­hance anti­body dependent cellular cyto­tox­icity. …

• In the ELOQUENT-3 trial, treat­ment with Empliciti plus poma­lido­mide and dexa­meth­a­sone (EPd) doubled median pro­gres­sion-free sur­vival and over­all re­sponse rate versus poma­lido­mide and dexa­meth­a­sone (Pd)¹
• Low dis­con­tinu­a­tion rates due to adverse reac­tions were observed with both EPd and Pd alone¹
• Empliciti, when used in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, can be admin­istered once monthly after first two cycles¹

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) approved Empliciti (elo­tuzu­mab) in­jec­tion for intra­venous use in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.¹ In ELOQUENT-3, a ran­dom­ized, open-label, Phase 2 trial, EPd dem­onstrated ben­e­fit in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma, doubling both median pro­gres­sion-free sur­vival (PFS) …

• Phase III MAIA study of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone in front line multiple myeloma met the pri­mary end­point (PFS) at a pre-planned interim analysis demonstrating the superiority of DRd over Rd
• Independent Data Moni­tor­ing Committee rec­om­mends releasing the interim analysis results and to follow patients for survival and long-term safety
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today topline results from the Phase III MAIA study (MMY3008) of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (DRd) versus Rd alone as treat­ment for newly diag­nosed patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The study met the pri­mary end­point of im­prov­ing pro­gres­sion free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.55 (95% CI 0.43 – 0.72), p …

• Phase III CASSIOPEIA study of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone in front line multiple myeloma met the pri­mary end­point of stringent Complete Response (sCR) after induction and con­sol­i­da­tion ther­apy
• Trial sponsored by the French Intergroupe Francophone du Myelome (IFM) in col­lab­o­ration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON)
• Data will be discussed with health author­i­ties for poten­tial regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today the study met its pri­mary end­point for Part 1 of the Phase III CASSI­OPEIA study (MMY3006) of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTD) versus VTD alone as frontline treat­ment for patients who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). The first part of the study met the pri­mary end­point of number of patients that achieved a sCR, which was reported in 28.9% of patients treated with …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated the Com­pany’s type II variation appli­ca­tion for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­cluding lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. Validation of the appli­ca­tion con­firms the sub­mission is com­plete and begins the EMA’s centralized review process.

“Given the need for new treat­ment …