• BLENREP is the first anti-BCMA (B-cell maturation an­ti­gen) ther­apy ap­prov­ed in the Euro­pean Union
• Marketing autho­ri­sa­tion follows the recent US ap­prov­al of BLEN­REP

London, United Kingdom (Press Release) – GlaxoSmithKline plc to­day an­nounced the Euro­pean Com­mis­sion has granted con­di­tional mar­ket­ing autho­ri­sa­tion for BLEN­REP (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. BLEN­REP is a first-in-class humanised anti-BCMA (B-cell maturation an­ti­gen) treat­ment for these patients whose …

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 …

• 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 …

• EC ap­prov­al based on data from first ran­dom­ized Phase 3 trial (ICARIA-MM) to report results eval­u­ating an anti-CD38 mono­clonal anti­body com­bined with poma­lido­mide and dexa­meth­a­sone (pom-dex)
• Sarclisa in com­bi­na­tion with pom-dex sig­nif­i­cantly reduced the risk of pro­gres­sion or death by 40% versus pom-dex alone
• Multiple myeloma is the sec­ond most common blood cancer, with approx­i­mately 40,000 new cases per year in Europe

Paris, France (Press Release) – The Euro­pean Com­mis­sion (EC) has approved Sarclisa® (isatuximab) in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma (MM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy.

Sarclisa is a mono­clonal anti­body (mAb) that binds to a spe­cif­ic epitope on the CD38 re­cep­tor of MM cells.

“The EC ap­prov­al of …

The European Com­mis­sion has approved Darzalex (dara­tu­mu­mab) for the treat­ment of multiple myeloma.

The approval means that, for the first time, myeloma patients in Europe will be able to be treated with Darzalex without having to enroll in a clin­i­cal trial.

The European Darzalex approval is for use of the drug as a single agent – meaning Darzalex by itself, with no other anti-myeloma ther­apy – in adults with re­lapsed and refractory multiple myeloma. Patients must have been pre­vi­ously treated with a pro­te­a­some inhibitor and with an immun­o­modu­la­tory agent, and …

The Euro­pean Com­mis­sion has approved Empliciti (elo­tuzu­mab) for the treat­ment of mul­ti­ple myeloma.

The ap­prov­al means that myeloma patients in Europe will now be able to be treated with Empliciti without having to en­roll in a clin­i­cal trial.

Empliciti's Euro­pean ap­prov­al comes on the heals of its ap­prov­al late last No­vem­ber in the United States, the mar­ket in which the drug re­ceived its first ever regu­la­tory ap­prov­al. As in the United States, Empliciti has been approved in Europe for use in com­bi­na­tion with Revlimid (lena­lido­mide) and dexa­meth­a­sone.

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