Applications sup­ported by pos­i­tive re­sults from the Phase 3 APOLLO study, which dem­onstrated longer pro­gres­sion-free sur­vival in patients re­ceiv­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab¹

RARITAN, N.J., Nov. 12, 2020 /PRNewswire/ -- The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the sub­mission of regu­la­tory appli­ca­tions to the U.S. Food and Drug Admin­istra­tion (FDA) and Euro­pean Medicines Agency (EMA) seek­ing ap­prov­al of the dara­tu­mu­mab sub­cu­tane­ous (SC) for­mu­la­tion, known as DAR­ZA­LEX FASPRO™ (dara­tu­mu­mab and hyal­uron­i­dase-fihj) in the U.S. and as DAR­ZA­LEX® SC in the Euro­pean Union (EU). The appli­ca­tions seek ap­prov­al of the com­bi­na­tion of DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (D-Pd) for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple …

• Second part of the Phase 3 CASSI­O­PEIA study of dara­tu­mu­mab as main­te­nance treat­ment for patients with newly diag­nosed mul­ti­ple myeloma eli­gible for au­tol­o­gous stem cell trans­plant met the pri­mary end­point of pro­gres­sion-free sur­vival at a pre-planned interim analysis
• Independent Data Mon­i­tor­ing Com­mit­tee rec­om­mends unblinding the study re­sults
• Based on the data, Janssen plans to discuss the po­ten­tial for a regu­la­tory sub­mission with health author­i­ties

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day pos­i­tive top­line re­sults from the sec­ond part of the Phase 3 CASSI­O­PEIA (MMY3006) study of dara­tu­mu­mab mono­therapy as main­te­nance treat­ment versus observation (no treat­ment) for patients with newly diag­nosed mul­ti­ple myeloma eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The sec­ond part of the study, which is being con­ducted by the French Intergroupe Francophone du Myelome (IFM) in col­lab­o­ration with the Dutch-Belgian Cooperative Trial Group for He­ma­tol­ogy On­col­ogy (HOVON) and …

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 …

• First and only anti-CD38 anti­body in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) to be approved in Canada^1,2
• SARCLISA™ in com­bi­na­tion with pom-dex sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death by 40% com­pared to pom-dex alone in a pivotal trial²
• Multiple myeloma is the third most common blood cancer in Canada³

Mississauga, ON (Press Release) – Sanofi Canada is pleased to an­nounce that Health Canada has approved SARCLISA™ in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of adults with re­lapsed and re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.²

"Immunotherapies like SARCLISA™ leverage the im­mune sys­tem to fight mul­ti­ple myeloma and we're seeing real progress in their ability to help patients. This was not the case over a decade ago," says Dr. …

Rockville, MD and Beijing, China (Press Release) – CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and com­mer­cializing inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts, to­day an­nounced that it sub­mitted a Clinical Trial Appli­ca­tion (CTA) (IND) with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) for CID-103, its novel anti-CD38 mono­clonal anti­body for the treat­ment of mul­ti­ple myeloma and other hema­to­logical malig­nan­cies.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "Submitting this CTA is an im­por­tant step in the clin­i­cal de­vel­op­ment of this promising ther­apy in our …

• New sub­cu­tane­ous, fixed-dose for­mu­la­tion of dara­tu­mu­mab reduces treat­ment time from hours to min­utes, with com­parable ef­fi­cacy and fewer in­fusion-related reac­tions^1,2
• Daratumumab is now the only approved sub­cu­tane­ous CD38-directed anti­body for the treat­ment of these mul­ti­ple myeloma in­di­ca­tions in Europe

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day that the Euro­pean Com­mis­sion (EC) has granted mar­ket­ing authori­sa­tion for DAR­ZA­LEX®▼ (dara­tu­mu­mab) sub­cu­tane­ous (SC) for­mu­la­tion for the treat­ment of adult patients with mul­ti­ple myeloma (MM). Dara­tu­mu­mab SC is admin­istered as a fixed dose, which sig­nif­i­cantly reduces treat­ment time, from hours to approx­i­mately three to five min­utes, when com­pared to dara­tu­mu­mab in­tra­venous (IV) for­mu­la­tion.¹ In addi­tion, only the first dose of dara­tu­mu­mab SC needs to be admin­istered in an en­viron­ment where resuscitation …

• Subcutaneous fixed-dosed for­mu­la­tion of DAR­ZA­LEX® (dara­tu­mu­mab) approved in Europe for the treat­ment of adult patients with mul­ti­ple myeloma
• Approval follows pos­i­tive opinion by Euro­pean Com­mit­tee for Medicinal Products for Human Use (CHMP) in April 2020 and applies to all cur­rent dara­tu­mu­mab in­di­ca­tions in front­line and re­lapsed / re­frac­tory settings
• Approval based on data from Phase III COLUMBA and Phase II PLEIADES stud­ies
• In the stud­ies, the fixed-dose sub­cu­tane­ous for­mu­la­tion reduced treat­ment time from hours to min­utes and dem­onstrated similar ef­fi­cacy and safety with sig­nif­i­cantly fewer in­fusion-related reac­tions com­pared with the in­tra­venous for­mu­la­tion

Copenhagen, Denmark; June 4, 2020 – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the Euro­pean Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for the sub­cu­tane­ous (SC) for­mu­la­tion of DAR­ZA­LEX® (dara­tu­mu­mab), for the treat­ment of adult patients with mul­ti­ple myeloma in all cur­rently approved dara­tu­mu­mab in­tra­venous (IV) for­mu­la­tion in­di­ca­tions in front­line and re­lapsed / re­frac­tory settings. The ap­prov­al follows a Positive Opinion by the CHMP of the Euro­pean Medicines Agency (EMA) in April 2020. The SC for­mu­la­tion is …