First inves­ti­ga­tional prod­uct being rec­om­mended for Break­­through Therapy Desig­na­tion in China

Somerset, NJ (Press Release) – Legend Bio­tech Corpo­ra­tion (NASDAQ:LEGN) an­nounced to­day that the China Center for Drug Evaluation, National Medical Products Admin­istra­tion (CDE, NMPA) has rec­om­mended Break­­through Therapy Desig­na­tion (BTD) for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells), an inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA) targeted chi­meric an­ti­gen re­cep­tor (CAR) T-cell ther­apy being studied for the treat­ment of adults with re­lapsed or re­frac­tory mul­ti­ple myeloma (RRMM).

The BTD for cilta-cel (LCAR-B38M CAR-T cells) is based on the on­go­ing Phase 2 CARTIFAN-1 study being con­ducted in China (MMY2002, NCT03758417, CTR20181007), the on­go­ing Phase 1b/2 CARTITUDE-1 study …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounced that the first patient has been en­rolled in the phase 2 PORT study. The study, which is ex­pected to be fully recruited in De­cem­ber 2020, is an open-label, ran­dom­ized, cross-over study which compares safety, tol­er­a­bil­ity and ef­fi­cacy of periph­eral or central in­tra­venous admin­istra­tion of mel­flu­fen in com­bi­na­tion with dexa­meth­a­sone in patients with re­lapsed re­frac­tory mul­ti­ple myeloma, RRMM. Up to 25 RRMM patients who have re­ceived at least two pre­vi­ous lines of ther­apy will be en­rolled.

"Patients who re­ceive anti-cancer treat­ment …

DARZALEX® SC reduces admin­istra­tion time from hours to min­utes and dem­onstrates con­sis­tent ef­fi­cacy with a re­duc­tion in admin­istra­tion-related reac­tions com­pared to in­tra­venous DAR­ZA­LEX® (dara­tu­mu­mab)

Toronto, ON (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day that Health Canada has approved DAR­ZA­LEX® SC (dara­tu­mu­mab), a new sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab.¹ DAR­ZA­LEX® SC is approved in four regi­mens across five in­di­ca­tions in patients with mul­ti­ple myeloma, most notably newly diag­nosed, trans­plant-ineligible patients as well as re­lapsed or re­frac­tory patients. As a fixed-dose for­mu­la­tion, DAR­ZA­LEX® SC can be admin­istered over approx­i­mately three to five min­utes, sig­nif­i­cantly less time than in­tra­venous (IV) DAR­ZA­LEX®, which is admin­istered over hours.² DAR­ZA­LEX® SC is the only sub­cu­tane­ous CD38-directed anti­body approved …

Lund, Sweden (Press Release) – Active Biotech (NASDAQ STOCKHOLM: ACTI) to­day an­nounces that the first patient has been dosed in the phase 1b/2a clin­i­cal study of tas­quini­mod for treat­ment of re­lapsed or re­frac­tory mul­ti­ple myeloma. The study, which is planned to recruit up to 54 patients, will estab­lish a max­i­mum tol­er­ated dose of tas­quini­mod as single agent and then in­ves­ti­gate tas­quini­mod in com­bi­na­tion with a stan­dard mul­ti­ple myeloma oral regi­men of ix­az­o­mib, lena­lido­mide, and dexa­meth­a­sone (IRd). For both single agent tas­quini­mod and the com­bi­na­tion of tas­quini­mod and IRd, exploratory ex­pan­sion cohorts will be …

• Phase 3 APOLLO ran­dom­ized study eval­u­ating sub­cu­tane­ous dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone versus poma­lido­mide and dexa­meth­a­sone alone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion-free sur­vival
• Janssen in­tends to discuss the data with health author­i­ties for po­ten­tial regu­la­tory sub­missions

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the Euro­pean Myeloma Network (EMN) in col­lab­o­ration with Janssen Re­search & De­vel­op­ment, LLC (Janssen) re­ported pos­i­tive re­­sults from the Phase 3 APOLLO (MMY3013) study of the sub­cu­tane­ous (SC) for­mu­la­tion of dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (Pd) versus Pd alone as treat­ment for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have pre­vi­ously been treated with lena­lido­mide (an immuno­modu­la­tory drug) and a pro­te­a­some in­hib­i­tor (PI). The study met the pri­mary …

• BLA sub­mission based on re­­sults from pivotal Phase 2 KarMMa study eval­u­ating ide-cel in heavily pre-treated patient pop­u­la­tion
• Companies are com­mit­ted to work­ing with the FDA to rapidly ad­vance ide-cel through the regu­la­tory re­­view process

Princeton, NJ and Cambridge, MA – Bristol Myers Squibb (NYSE: BMY) and blue­bird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the sub­mission of their Bio­logics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. This sub­mission provides fur­ther details on the Chemistry, Manu­fac­tur­ing and Con­trols (CMC) module to address the out­stand­ing …

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency (EMA) adopted a pos­i­tive opinion rec­om­mending the ap­prov­al of be­lan­ta­mab mafo­dotin as mono­therapy for the treat­ment of mul­ti­ple myeloma in adult patients, who have re­ceived at least four prior ther­a­pies and whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent, and an anti-CD38 mono­clonal anti­body, and who have dem­onstrated dis­ease pro­gres­sion on the last ther­apy.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head …