• 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 …

• 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 …

• 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 …

Paris, France (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for review the Biologics License Application (BLA) for isatuximab for the treat­ment of patients with re­lapsed / re­frac­tory multiple myeloma (RRMM). The target action date for the FDA de­ci­sion is April 30, 2020. Isatuximab is an inves­ti­ga­tional mono­clonal anti­body that targets a specific epitope on the CD38 re­cep­tor of a plasma cell.

The BLA is based on pos­i­tive results from ICARIA-MM, an open-label pivotal Phase 3 clin­i­cal trial of isatuximab in patients with RRMM. ICARIA-MM is the first pos­i­tive ran­dom­ized …

• Study eval­u­ated the benefit of isatuximab in com­bi­na­tion with standard of care in prolonging pro­gres­sion free sur­vival as com­pared to standard of care in patients with re­lapsed / re­frac­tory multiple myeloma
• First ran­dom­ized Phase 3 trial to eval­u­ate the benefit of adding a mono­clonal anti­body to poma­lido­mide and dexa­meth­a­sone for treat­ment of re­lapsed / re­frac­tory multiple myeloma
• Multiple ongoing Phase 3 studies with isatuximab, an inves­ti­ga­tional agent, in com­bi­na­tion with standard of care ther­a­pies in newly diag­nosed and re­lapsed / re­frac­tory multiple myeloma

Paris, France (Press Release) – The pivotal Phase 3 trial of isatuximab in patients with re­lapsed / re­frac­tory multiple myeloma met the pri­mary end­point of prolonging pro­gres­sion free sur­vival in patients treated with isatuximab in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone versus poma­lido­mide and low-dose dexa­meth­a­sone alone (standard of care).

Results will be sub­mitted to an upcoming medical meeting and are antic­i­pated to form the basis of regu­la­tory sub­missions planned for later this year.

"We are ex­cited by these results, …

The 2016 annual meeting of the American Society of Clinical Oncology (ASCO) is now history, but there's still plenty of news to report from the meeting.

In this edition of the Beacon's ASCO multiple myeloma updates, the focus is on pre­sen­ta­tions that took place the last two days of the ASCO meet­ing – this past Monday and Tuesday – and which con­cerned poten­tial new multiple myeloma ther­a­pies.

There was a block of oral pre­sen­ta­tions related to poten­tial new myeloma ther­a­pies that took place Tuesday morning, and all those pre­sen­ta­tions are covered in this article. …