Approval broadens DAR­ZA­LEX label to in­clude fifth treat­ment op­tion in the re­lapsed / re­frac­tory setting and rep­re­sents the eighth ap­prov­ed in­di­ca­tion for DAR­ZA­LEX

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the U.S. Food and Drug Admin­istra­tion (FDA) ap­prov­al of DAR­ZA­LEX® (dara­tu­mu­mab) in com­bi­na­tion with Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy. DAR­ZA­LEX® has been ap­prov­ed in com­bi­na­tion with two car­filz­o­mib dosing regi­mens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on pos­i­tive re­­sults from the Phase 3 CANDOR and Phase 1b EQUULEUS stud­ies, rep­re­senting the first-ever ap­prov­al of an …

• DARZALEX® (dara­tu­mu­mab) ap­prov­ed by U.S. FDA in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy
• Approval based on the Phase 3 CANDOR study
• Approval marks eighth U.S. FDA ap­prov­al for DAR­ZA­LEX

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 DAR­ZA­LEX® (dara­tu­mu­mab) in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone (DKd) for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy. A supple­mental Biologics License Appli­ca­tion (sBLA) for this in­di­ca­tion was sub­mitted by Genmab’s licensing part­ner, Janssen Bio­tech, Inc. (Janssen), in Feb­ru­ary 2020. In August 2012, Genmab granted …

• BLENREP is a first-in-class anti-BCMA (B-cell maturation an­ti­gen) ther­apy for patients whose dis­ease has progressed de­spite prior treat­ment with an immuno­modu­la­tory agent, pro­te­a­some in­hib­i­tor and anti-CD38 anti­body
• BLENREP is the fifth major med­i­cine ap­prov­al for GSK in 2020

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) an­nounced the US Food and Drug Admin­istra­tion (FDA) has approved BLEN­REP (belantamab mafo­dotin-blmf) as a mono­therapy treat­ment for adult patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an anti-CD38 mono­clonal anti­body, a pro­te­a­some in­hib­i­tor and an immuno­modu­la­tory agent. This in­di­ca­tion is approved under ac­cel­er­ated ap­prov­al based on re­sponse rate. Continued ap­prov­al for this in­di­ca­tion may be con­tin­gent upon veri­fi­ca­tion and description of clin­i­cal ben­e­fit 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 …

• Sarclisa in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death by 40% com­pared to pom-dex alone in a pivotal trial
• FDA ap­­prov­al based on data from the only ran­dom­ized Phase 3 trial (ICARIA-MM) to eval­u­ate an anti-CD38 in com­bi­na­tion with pom-dex that has pre­sented results to date
• Multiple myeloma is the second most common blood cancer, affecting more than 130,000 patients in the U.S.; approx­i­mately 32,000 Americans are diag­nosed with multiple myeloma each year

Bridgewater, NJ (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has approved Sarclisa® (isatuximab-irfc) in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) for the treat­ment of adults with re­lapsed re­frac­tory multiple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. Sarclisa is ex­pec­ted to be avail­able to patients in the U.S. shortly.

Sarclisa is a mono­clonal anti­body that binds to the CD38 re­cep­tor on multiple myeloma cells.

"Today's FDA ap­­prov­al …

Silver Spring, MD (Press Release) – Today, the U.S. Food and Drug Admin­istra­tion approved Sarclisa (isatuximab-irfc), in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. Sarclisa, admin­istered through in­tra­venous (IV) in­fusion, is a CD38-directed cytolytic anti­body that works by helping cer­tain cells in the immune sys­tem attack multiple myeloma cancer cells.

“Targeting cells has led to the devel­op­ment of im­por­tant on­col­ogy treat­ments. While there is no cure for multiple myeloma, Sarclisa is …

• XPOVIO is the First and Only Nuclear Export Inhibitor Approved by the FDA
• XPOVIO is the First and Only Prescription Medicine Approved by the FDA for the Treatment of Patients with Multiple Myeloma whose Disease is Refractory to Proteasome Inhibitors, Immunomodulatory Agents, and an Anti-CD38 Monoclonal Antibody
• Karyopharm to Hold an Investor Conference Call and Webcast at 1:30 PM ET Today

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an on­col­ogy-focused pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved oral XPOVIOTM (selinexor), a nuclear export inhibitor, in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed or refractory multiple myeloma (RRMM) who have received at least four prior ther­a­pies and whose disease is refractory to at least two pro­te­a­some inhibitors, at least two immuno­modu­la­tory agents, and an anti-CD38 mono­clonal anti­body. This indi­ca­tion …