• Australia's Therapeutic Goods Admin­istra­tion approves APLIDIN (plitidepsin) for re­lapsed / refractory multiple myeloma patients
• APLIDIN will con­tinue to be made avail­able to eli­gible patients via a Compassionate Access Program, pending reim­burse­ment
• APLIDIN is a first-in-class anti-cancer agent approved to treat multiple myeloma, which has one of the lowest survival rates in cancer

Singapore (Press Release) – Australian multiple myeloma patients will have world-first access to a new first-in-class drug developed to treat the disease, fol­low­ing approval by Australian regu­la­tory author­i­ties.

The drug, APLIDIN (plitidepsin) …

Summit, NJ and Cambridge, MA (Press Release) – Celgene Corpo­ra­tion (Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the com­ple­tion of en­roll­ment for the KarMMa pivotal study of bb2121, the com­pa­nies’ lead inves­ti­ga­tional anti-BCMA CAR T cell ther­apy can­di­date for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. bb2121 is being devel­oped as part of a Co-Development, Co-Promote and Profit Share Agreement be­tween Celgene and bluebird bio.

“We con­tinue to be ex­cited about bb2121 as a poten­tial first-in-class BCMA-targeted ther­apy for patients with mul­ti­ple myeloma,” said Alise Reicin, M.D., Pres­i­dent, Global …

• CHMP issued pos­i­tive opinion on split dosing regi­men for DARZALEX
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion sup­ported by data from EQUULEUS (MMY1001) clin­i­cal trial

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 updating the existing mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in the European Union. The recom­men­da­tion is to update the Summary of Product Characteristics in order to provide health care professionals the option to split the first in­fusion of DARZALEX over two consecutive days. The Type II variation …

• SEA-BCMA is a Novel Empowered Antibody Targeting BCMA for Multiple Myeloma
• Adds to Seattle Genetics’ Robust Clinical-Stage Development Pipeline across Multiple Hematologic and Solid Tumors

Bothell, WA (Press Release) – Seattle Genetics, Inc. (Nasdaq:SGEN) announced today dosing of the first patient in a phase 1 clin­i­cal trial eval­u­ating the safety and tolerability of SEA-BCMA for patients with re­lapsed or refractory multiple myeloma (MM). SEA-BCMA is an inves­ti­ga­tional anti­body empowered using Seattle Genetics’ pro­pri­e­tary Sugar Engineered Antibody (SEA) tech­nology designed to en­hance anti­body dependent cellular cyto­tox­icity. …

Clinical Trials to Advance Across Multiple He­ma­tol­ogy Programs

Florham Park, NJ (Press Release) – Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, an­nounces to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has granted an exemption to the Import Alert placed on the Centre for Probe De­vel­op­ment and Com­mer­cial­i­za­tion (CPDC), the sole supplier of the CLR 131. The exemption for CLR 131 is ef­fec­tive im­medi­ately for all he­ma­tol­ogy stud­ies and, in re­sponse, Cellectar is preparing to dose patients in the sec­ond frac­tion­ated dose cohort of the …

• In the ELOQUENT-3 trial, treat­ment with Empliciti plus poma­lido­mide and dexa­meth­a­sone (EPd) doubled median pro­gres­sion-free sur­vival and over­all re­sponse rate versus poma­lido­mide and dexa­meth­a­sone (Pd)¹
• Low dis­con­tinu­a­tion rates due to adverse reac­tions were observed with both EPd and Pd alone¹
• Empliciti, when used in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, can be admin­istered once monthly after first two cycles¹

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) approved Empliciti (elo­tuzu­mab) in­jec­tion for intra­venous use in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.¹ In ELOQUENT-3, a ran­dom­ized, open-label, Phase 2 trial, EPd dem­onstrated ben­e­fit in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma, doubling both median pro­gres­sion-free sur­vival (PFS) …

San Diego, CA (Press Release) – Fortis Therapeutics, Inc., an immuno-oncology bio­tech devel­op­ing a novel anti­body-drug con­ju­gate (ADC) against CD46, today announced the U.S. Food and Drug Admin­istra­tion (FDA) has cleared two inves­ti­ga­tional new drug (IND) appli­ca­tions for the com­pany’s lead can­di­date, FOR46, for the treat­ment of metastatic castration-resistant prostate cancer and late-stage multiple myeloma. The Phase 1 trial of FOR46 in metastatic castration-resistant prostate cancer is planned to launch by the end of the year. The second pro­gram, in late-stage multiple myeloma, is ex­pec­ted to move into clin­i­cal trials in early …