Study met Primary Endpoint of Non-Inferiority Versus Zoledronic Acid in Delaying Bone Complications Known as Skeletal-Related Events

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that a Phase 3 study eval­u­ating XGEVA® (denosumab) versus zoledronic acid met the pri­mary end­point of non-inferiority (hazard ratio = 0.98, 95 per­cent CI, 0.85 - 1.14) in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma. The sec­ond­ary end­points of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met. The hazard ratio of XGEVA versus zoledronic acid for over­all survival was 0.90 (95 per­cent CI, 0.70 - 1.16). …

Data Indicates Meaningful Clinical Benefit in High-risk Multiple Myeloma Patients

Zug, Switzerland and New York, NY (Press Release) – SELLAS Life Sciences Group (SELLAS or the Com­pany), a late-stage bio­pharma­ceutical com­pany focused on the devel­op­ment of novel cancer immuno­ther­a­pies and thera­peutics for a broad range of cancer indi­ca­tions, today reported positive results from the Company's phase II study of its WT1 first-in-class immuno­thera­peutic anti-cancer treat­ment in multiple myeloma (MM) patients fol­low­ing au­tol­o­gous stem cell trans­plan­ta­tion (ASCT). Initial results indicate for the first time a meaningful clin­i­cal benefit among high-risk multiple myeloma patients, …

• U.S. FDA grants Priority Review to dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone for re­lapsed multiple myeloma — February 17, 2017 PDUFA date
• U.S. FDA grants Standard Review to dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for re­lapsed or refractory multiple myeloma — June 17, 2017 PDUFA date

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Priority Review to the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) in combi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy. The sBLA was submitted by Genmab's licensing partner, Janssen Biotech, Inc. in August 2016. Priority Review …

Amgen to Hold Analyst Call Today at 8:30 a.m. ET

Thousdand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 CLARION trial, which eval­u­ated an inves­ti­ga­tional regi­men of KYPROLIS® (car­filz­o­mib), mel­phalan and pred­ni­sone (KMP) versus Velcade® (bor­tez­o­mib), mel­phalan and pred­ni­sone (VMP) for 54 weeks in patients with newly diag­nosed multiple myeloma who were in­eli­gible for hema­to­poietic stem-cell trans­plant. The trial did not meet the pri­mary end­point of superiority in pro­gres­sion-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 per­cent CI, 0.75 - 1.10). While the data …

Madrid, Spain (Press Release) – PharmaMar (MSE:PHM) has announced today the sub­mission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for Aplidin® (pliti­depsin) in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of re­lapsed/refractory multiple myeloma (MM). This is a type of blood cancer which rep­re­sents 10% of all hema­to­logical malig­nan­cies.

PharmaMar has gone through with this appli­ca­tion given the positive data obtained from the ran­domized, Phase III ADMYRE clin­i­cal trial, where the efficacy and safety of Aplidin® with dexa­meth­a­sone versus dexa­meth­a­sone alone in patients with re­lapsed/refractory MM after at …

• If authorized, NINLARO will provide a new treat­ment option for European patients with multiple myeloma who have received at least one prior ther­apy
• Opinion based on TOURMALINE-MM1 trial, in which NINLARO plus lena­lido­mide and dexa­meth­a­sone dem­onstrated 6 month im­prove­ment in pro­gres­sion-free survival versus the placebo regi­men

Cambridge, MA, and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the con­di­tional approval of NINLARO^TM (ixazomib) capsules in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy. If the European Com­mis­sion ratifies the CHMP’s opinion and authori­za­tion is granted, NINLARO will be the …

Thousand Oaks, CA, and Ingelheim, Germany (Press Release) – Amgen (NASDAQ: AMGN) and Boehringer Ingelheim today announced that Amgen has acquired global devel­op­ment and commercial rights from Boehringer Ingelheim for BI 836908 (AMG 420), a bispecific T cell engager (BiTE®) that targets B-cell maturation an­ti­gen (BCMA), a poten­tial target for multiple myeloma. BI 836908 (AMG 420) is cur­rently in Phase 1 studies. BI 836908 (AMG 420) was originally licensed to Boehringer Ingelheim by Micromet before the com­pany was acquired by Amgen in 2012.

Under the provisions of the agree­ment, Amgen will work with Boehringer Ingelheim to assume re­spon­si­bil­ity­ …