• Median pro­gres­sion-free sur­vival and over­all re­sponse rate doubled among patients re­ceiv­ing EPd com­pared to poma­lido­mide and low-dose dexa­meth­a­sone alone
• Second Empliciti-based com­bi­na­tion approved in Europe for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Com­mis­sion (EC) has approved Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. This ap­prov­al is based on data from the ELOQUENT-3 trial in which EPd doubled both median pro­gres­sion-free sur­vival (PFS) and …

Belantamab mafo­dotin (GSK2857916) on track for regu­la­tory sub­mission by the end of 2019

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced pos­i­tive headline re­­sults from the pivotal DREAMM-2 open-label, ran­domised study of two doses of be­lan­ta­mab mafo­dotin (GSK2857916).

The 196 patients in the trial had re­lapsed mul­ti­ple myeloma, were re­frac­tory to an immuno­modu­la­tory drug, a pro­te­a­some in­hib­i­tor, and to treat­ment with an anti-CD38 anti­body. The two-arm study met its pri­mary objective and dem­onstrated a clin­i­cally meaningful over­all re­sponse rate with be­lan­ta­mab mafo­dotin in the patient pop­u­la­tion. The safety and tol­er­a­bil­ity profile was con­sis­tent with that ob­served in DREAMM-1, the first …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency has adopted a pos­i­tive opinion on a Type-II variation appli­ca­tion for Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. The CHMP recom­men­da­tion will now be reviewed by the Euro­pean Com­mis­sion, …

POMALYST®, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, provides a new medication option for patients living with multiple myeloma

Toronto, ON (Press Release) – Celgene Inc. announced today that Health Canada has approved a POMALYST® (poma­lido­mide)-based triplet com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone. This is a new treat­ment option for patients with multiple myeloma (MM) who have received at least one prior treat­ment regi­men that in­cluded REVLIMID® (lena­lido­mide).

POMALYST® is an oral medication taken daily and is indicated, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of adult patients with MM who have received at least one prior treat­ment regi­men that in­cluded lena­lido­mide.^1,2

"The treat­ment landscape for multiple myeloma has sig­nif­i­cantly changed …

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 …

• 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 …

Silver Spring, MD (Press Release) – Today, the U.S. Food and Drug Admin­istra­tion granted accelerated approval to Xpovio (selinexor) tablets in com­bi­na­tion with the corticosteroid dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed refractory multiple myeloma (RRMM) who have received at least four prior ther­a­pies and whose disease is resistant to several other forms of treat­ment, in­clud­ing at least two pro­te­a­some inhibitors, at least two immuno­modu­la­tory agents, and an anti-CD38 mono­clonal anti­body.

“While there is no cure for multiple myeloma, there are FDA-approved treat­ments to target the cancer and slow down …