• 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 …

• IKEMA trial results released early based on recom­men­da­tion of an Independent Data Monitoring Com­mit­tee
• Addition of Sarclisa sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death com­pared to car­filz­o­mib and dexa­meth­a­sone alone
• Results will be sub­mitted to an upcoming medical meeting and form the basis for regu­la­tory sub­missions later this year

Paris, France (Press Release) – The Phase 3 IKEMA clin­i­cal trial eval­u­ating Sarclisa® (isatuximab) added to car­filz­o­mib and dexa­meth­a­sone met the pri­mary end­point at its first planned interim analysis, demonstrating sig­nif­i­cantly prolonged pro­gres­sion-free sur­vival com­pared to standard of care car­filz­o­mib and dexa­meth­a­sone alone in patients with re­lapsed multiple myeloma. There were no new safety signals identified in this study.

“When Sarclisa was added to standard-of-care treat­ment car­filz­o­mib and dexa­meth­a­sone in this phase 3 trial, results clearly dem­onstrated a sig­nif­i­cant re­duc­tion in …

• 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 …

Shanghai, China and Rockville, MD (Press Release) – I-Mab (NASDAQ: IMAB), a clin­i­cal stage bio­pharma­ceu­tical com­pany com­mit­ted to the discovery, de­vel­op­ment and com­mer­cial­iza­tion of novel or highly dif­fer­en­ti­ated biologics to treat dis­eases with sig­nif­i­cant unmet med­i­cal needs, and MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR), to­day jointly an­nounced that the first patient has been dosed in a phase 3 clin­i­cal study in main­land China to eval­u­ate MorphoSys’ inves­ti­ga­tional human CD38 anti­body TJ202 / MOR202 in com­bi­na­tion with lena­lido­mide plus dexa­meth­a­sone in patients with re­lapsed or re­frac­tory multiple myeloma (r/r …

Initiation of the clin­i­cal trial triggers $50 million mile­stone pay­ment from AbbVie

South San Francisco, CA (Press Release) – Harpoon Thera­peutics, Inc. (NASDAQ: HARP), a clin­i­cal-stage immuno­therapy com­pany devel­op­ing a novel class of T cell engagers, to­day announced that the first patient has been dosed with HPN217 in a Phase 1/2 clin­i­cal trial focused on re­lapsed, re­frac­tory multiple myeloma (RRMM). HPN217 is being devel­oped under a global license and option agree­ment with AbbVie Inc. (NYSE:ABBV) and dosing of the first patient in a clin­i­cal trial has triggered a $50 million mile­stone pay­ment to Harpoon. HPN217 targets B-cell maturation an­ti­gen (BCMA), a well-validated an­ti­gen ex­pressed …

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. …