• CHMP issued pos­i­tive opinion for DARZALEX for front line multiple myeloma
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion based on data from Phase III ALCYONE study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a pos­i­tive opinion rec­om­mending broadening the existing mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in the European Union. The recom­men­da­tion is for the use of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP) for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell …

London and Oxford, United Kingdom (Press Release) – GlaxoSmithKline plc and Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell ther­apy to treat cancer, today announced the transition of the devel­op­ment pro­gram for GSK3377794 (GSK ‘794), an NY-ESO SPEAR T-cell ther­apy, to GSK. As a result of the transition, GSK assumes full responsibility for future research, devel­op­ment, and poten­tial com­mer­cial­iza­tion of this pioneering ther­apy, and Adaptimmune will receive $27.5 million (£21.2 million) from GSK.

Dr. Hal Barron, Pres­i­dent R&D, GSK said, “The data we’ve seen for GSK ‘794 point to the poten­tially transformational …

New York, NY (Press Release) – SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the devel­op­ment of novel cancer immuno­therapies for a broad range of cancer indi­ca­tions, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track desig­na­tion to the Company’s lead asset, galin­pepimut-S (GPS), for the treat­ment of multiple myeloma (MM). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types.

The Company reported …

Company Plans to Complete Submission During the Second Half of 2018

Newtown, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the Company has ini­ti­ated a rolling sub­mission of a New Drug Application (NDA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking accelerated approval for selinexor, its novel, oral SINE com­­pound, as a new treat­ment for patients with penta-refractory multiple myeloma. Patients with penta-refractory myeloma have pre­vi­ously received the two pro­te­a­some inhibitors (PIs), Velcade® (bor­tez­o­mib) and Kyprolis® (car­filz­o­mib), the two immuno­modu­la­tory drugs (IMiDs), Revlimid® (lena­lido­mide) and Pomalyst® (poma­lido­mide), and the anti-CD38 mono­clonal anti­body Darzalex® (dara­tu­mu­mab), …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the ran­dom­ized, Phase 3 TOURMALINE-MM3 study met its pri­mary end­point, demonstrating single-agent oral NINLARO® (ixazomib) as a main­te­nance ther­apy resulted in a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free survival (PFS) versus placebo. The trial eval­u­ated the effect of NINLARO as a main­te­nance ther­apy in adult patients diag­nosed with multiple myeloma who responded to high-dose ther­apy (HDT) and au­tol­o­gous stem cell trans­plant (ASCT). Takeda plans to submit data from the trial to regu­la­tory agencies around the world. NINLARO …

Stamford, CT (Press Release) – Purdue Pharma L.P. today announced successful completion of a first-in-human Phase 1 dose escalation study of tino­sta­mus­tine in patients with re­lapsed or refractory hema­to­logical malig­nan­cies for which there are no avail­able ther­a­pies. The study eval­u­ated the safety and phar­ma­co­ki­netics, and sought to determine the maximum tolerated dose and inform a Phase 2 dose of tino­sta­mus­tine.¹

The multi-acting ther­apy can­di­date tino­sta­mus­tine, pre­vi­ously known as EDO-S101, is a novel and poten­tially first-in-class alkylating deacetylase inhibitor (AK-DACi) ther­apy being studied for its poten­tial to im­prove access to the DNA strands …

• Kyprolis, lena­lido­mide, and dexa­meth­a­sone extended median over­all survival in re­lapsed or refractory multiple myeloma patients to 48 months
• Kyprolis is the first and only treat­ment to dem­onstrate over­all survival benefits in two Phase 3 studies in re­lapsed and refractory multiple myeloma

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental New Drug Application (sNDA) to add the positive over­all survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for KYPROLIS® (car­filz­o­mib). Data added to the label showed that KYPROLIS, lena­lido­mide and dexa­meth­a­sone (KRd) sig­nif­i­cantly reduced the risk of death by 21 per­cent and extended over­all survival by 7.9 months versus lena­lido­mide and dexa­meth­a­sone alone …