• Positive CHMP opinion based on data from ICARIA-MM, the first ran­dom­ized Phase 3 trial to eval­u­ate an anti-CD38 in com­bi­na­tion with pom-dex
• Sarclisa in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death in adults by 40% com­pared to pom-dex alone in the trial
• Sarclisa was approved by the FDA on March 2 in com­bi­na­tion with pom-dex for the treat­ment of cer­tain adults with RRMM
• Multiple myeloma remains an incurable cancer asso­ci­ated with sig­nif­i­cant patient burden and need for addi­tional treat­ments

Paris, France (Press Release) – The European Medicines Agency’s Com­mit­tee for Medicinal Products for Human Use (CHMP) has adopted a pos­i­tive opinion for Sarclisa® (isatuximab). The CHMP rec­om­mends Sarclisa 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.

The European Com­mis­sion …

Phase 3 trial did not meet pri­mary end­point of pro­gres­sion-free sur­vival in patients not eli­gible for trans­plant

Princeton, NJ (Press Release) – Bristol Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced top­line re­­sults from ELOQUENT-1, a Phase 3, ran­dom­ized, open-label trial eval­u­ating the com­bi­na­tion of Empliciti (elo­tuzu­mab) plus Revlimid (lena­lido­mide) and dexa­meth­a­sone (ERd), versus Revlimid and dexa­meth­a­sone alone (Rd), in patients with newly diag­nosed, pre­vi­ously untreated mul­ti­ple myeloma who are trans­plant in­eli­gible. Both treat­ments were admin­istered con­tin­uously until dis­ease pro­gres­sion. At final analysis, the addi­tion of Empliciti did not show a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival (PFS), the study’s pri­mary end­point. The safety profile of ERd was generally con­sis­tent …

• 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 …

• 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, …

Shanghai, China (Press Release) – I-Mab Bio­pharma­ ("I-Mab"), a global bio­pharma­ceu­tical com­pany based in China and the United States and focused on the discovery and devel­op­ment of novel or highly dif­fer­en­ti­ated biologics in immuno-oncology and auto­immune dis­eases today announced the dosing of the first patient in mainland China in its reg­is­tra­tional study eval­u­ating its human CD38 anti­body (TJ202/MOR202) in patients with re­lapsed or re­frac­tory multiple myeloma (MM).

I-Mab ini­ti­ated two reg­is­tra­tional trials with TJ202 / MOR202 in re­lapsed or re­frac­tory MM in Taiwan in early 2019 and ex­panded these trials into mainland China in …

• 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 …