• 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 …

• Subcutaneous for­mu­la­tion of dara­tu­mu­mab, DAR­ZA­LEX FASPRO™, approved by the U.S. FDA for the treat­ment of patients with mul­ti­ple myeloma
• 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 (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab, DAR­ZA­LEX FASPRO™ (dara­tu­mu­mab and hyal­uron­i­dase-fihj). The Biologics License Appli­ca­tion (BLA) for this for­mu­la­tion was sub­mitted by Genmab’s licensing part­ner, Janssen Biotech, Inc. (Janssen) in July 2019. DAR­ZA­LEX FASPRO is approved for the treat­ment of adult patients with mul­ti­ple myeloma: in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone in newly diag­nosed patients who are …

• New sub­cu­tane­ous for­mu­la­tion reduces the time taken for patients to re­ceive dara­tu­mu­mab treat­ment from hours to approx­i­mately three to five min­utes, with similar ef­fi­cacy and fewer in­fusion-related reac­tions com­pared to in­tra­venous admin­istra­tion^1,2
• If approved, dara­tu­mu­mab sub­cu­tane­ous for­mu­la­tion will be the first mono­clonal anti­body approved in Europe for sub­cu­tane­ous admin­istra­tion for patients with mul­ti­ple myeloma
• Positive Opinion is based on data from the Phase 3 COLUMBA (MMY3012) and Phase 2 PLEIADES (MMY2040) stud­ies

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency (EMA) has issued a Positive Opinion rec­om­mending ap­­prov­al for DAR­ZA­LEX®▼ (dara­tu­mu­mab) sub­cu­tane­ous (SC) for­mu­la­tion for the treat­ment of adult patients with mul­ti­ple myeloma in front­line and re­lapsed / re­frac­tory settings. The novel SC for­mu­la­tion of dara­tu­mu­mab is co-formulated with recombinant human hyal­uron­i­dase PH20 (rHuPH20) [Halozyme's ENHANZE® drug de­livery tech­nology] and reduces …

San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO) to­day an­nounced the sub­mission of a New Drug Appli­ca­tion (NDA) to the Ministry of Health, Labour and Welfare (MHLW) by Janssen Pharma­ceu­tical K.K. (Janssen) seek­ing ap­­prov­al of a new sub­cu­tane­ous (SC) for­mu­la­tion of dara­tu­mu­mab, an in­tra­venous (IV) treat­ment approved for patients with mul­ti­ple myeloma.

"We are pleased to see this New Drug Appli­ca­tion sub­mission in Japan, which builds on Janssen's prior regu­la­tory sub­missions in the U.S. and EU that are cur­rent under re­view," said Dr. Helen Torley, pres­i­dent and chief exec­u­tive of­fi­cer. …

Application is based on pos­i­tive data from the Phase 3 CANDOR study, which were pre­sented at the 2019 American Society of Hematology Annual Meeting

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 Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for re­lapsed / re­frac­tory multiple myeloma. The sBLA is sup­ported by results from the Phase 3 CANDOR study, which com­pared treat­ment with DKd to car­filz­o­mib and dexa­meth­a­sone (Kd) in patients with multiple myeloma who re­lapsed after one to three prior lines of ther­apy.

"While we con­tinue to …

• DARZALEX® (dara­tu­mu­mab) approved in Europe in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant
• Approval follows pos­i­tive opinion by European Com­mit­tee for Medicinal Products for Human Use (CHMP) in De­cem­ber
• Approval based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark; Jan­u­ary­ 20, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The EC approval follows a pos­i­tive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in De­cem­ber 2019. In August 2012, Genmab granted Janssen Biotech, …

• If approved by the European Com­mis­sion, the dara­tu­mu­mab-VTd regi­men would rep­re­sent the first thera­peutic option in­di­cated for newly diag­nosed patients who are eli­gible for a stem cell trans­plant in six years¹
• Since launch, dara­tu­mu­mab has been used to treat more than 100,000 patients world­wide²

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has rec­om­mended broadening the existing mar­ket­ing authori­sa­tion for Darzalex®▼ (dara­tu­mu­mab) to in­clude the use of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) for the treat­ment of adult patients with newly diag­nosed patients with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

The Positive Opinion is sup­ported by data …