• Expansion of Indication Offers Patients a New Treatment Option
• Approval Based on Safety and Efficacy Data From the Largest Inter­na­tional Multiple Myeloma Clinical Trial Ever Conducted

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental Biologics License Application (sBLA) for XGEVA® (denosumab) to expand the cur­rently approved indi­ca­tion for the prevention of skeletal-related events in patients with bone metastases from solid tumors to in­clude patients with multiple myeloma. The approval is based on data from the pivotal Phase 3 '482 study, the largest inter­na­tional multiple myeloma clin­i­cal trial ever conducted, which enrolled 1,718 patients.

"Up to …

Madrid, Spain (Press Release) – PharmaMar (MCE: PHM) has announced the initiation of the re-examination process by the European Medicines Agency (EMA) for Aplidin® (plitidepsin) for the indi­ca­tion of re­lapsed and refractory multiple myeloma.

PharmaMar believes that this novel molecule could become part of the thera­peutic arsenal avail­able for the treat­ment of multiple myeloma in Europe.

It is worth noting that the re-examination procedure is handled by the EMA´s CHMP and usually lasts around 4 months. It concludes with either the con­firmation of the negative opinion or with the issuing of a new …

Penn study finds pro­te­a­some inhibitor leads to higher than ex­pec­ted rates of cardiovascular adverse events

Philadelphia, PA (Press Release) – The pro­te­a­some inhibitor car­filz­o­mib has taken on an in­creas­ing role in the treat­ment of multiple myeloma, but new research from the Abramson Cancer Center of the University of Pennsylvania shows the ther­apy comes with the risk of cardiovascular problems in a higher than ex­pec­ted per­cent­age of patients. An analysis of past studies shows 18 per­cent of multiple myeloma patients receiving car­filz­o­mib ex­peri­ence cardiovascular adverse events (CVAE) such as hyper­tension, heart failure, heart attacks, …

• Legend to re­ceive an up­front pay­ment of $350 mil­lion, as well as addi­tional devel­op­ment, pro­duc­tion per­for­mance, regu­la­tory and sales mile­stone pay­ments
• Legend and Janssen to co-develop and co-promote CAR T-cell ther­apy for mul­ti­ple myeloma
• Profits and costs to be shared 50/50 world­wide, ex­clu­sive Greater China where 70 per­cent to Legend and 30 per­cent to Janssen

Nanjing, China (Press Release) – Legend Biotech, a sub­sid­i­ary of GenScript Biotech Corpo­ra­tion (HKEx: 1548) that de­vel­ops inno­va­tive CAR T-cell immuno­therapy targeting mul­ti­ple myeloma, an­nounced to­day it has executed a stra­te­gic col­lab­o­ration agree­ment to jointly de­vel­op and com­mer­cial­ize the LCAR-B38M based prod­ucts with Janssen Biotech, Inc. ("Janssen").

According to the terms of the agree­ments, the com­pa­nies have agreed to jointly share the devel­op­ment, pro­duc­tion and com­mer­cial­iza­tion ac­­tiv­i­ties, with a 50/50 profit-loss sharing agree­ment for the world-wide mar­ket …

CAR-T BCMA in De­vel­op­ment for Patients with Multiple Myeloma

Horsham, PA (Press Release) – Janssen Bio­tech, Inc. (“Janssen”), a Janssen Pharma­ceu­tical Com­pany of John­son & John­son, an­nounced to­day that it has entered into a world­wide col­lab­o­ration and license agree­ment with Legend Bio­tech USA Inc. and Legend Bio­tech Ireland Limited (“Legend”), sub­sid­i­aries of Genscript Bio­tech Corpo­ra­tion, to de­vel­op, manu­fac­ture and com­mer­cial­ize a chi­meric an­ti­gen re­cep­tor (CAR) T-cell drug can­di­date, LCAR-B38M, which spe­cif­i­cally targets the B-cell maturation an­ti­gen (BCMA). LCAR-B38M is cur­rently ac­cepted for re­view by the China Food and Drug Admin­istra­tion (CFDA) and in the planning phase of clin­i­cal stud­ies in the United …

As ex­pec­ted after the Company announcement of the 8th of November, the Committee for Medicinal Products for Human Use (CHMP), belonging to the EMA, has emitted an opinion against the approval of Aplidin® for the treat­ment of multiple myeloma.

Madrid, Spain (Press Release) – As ex­pec­ted in the announcement made by PharmaMar on November 8th, the Committee for Medicinal Products for Human Use (CHMP) has finally emitted its opinion against the approval of the Marketing Authorization Application (MAA) of Aplidin® (plitidepsin), for the treat­ment of patients with re­lapsed multiple myeloma, in com­bi­na­tion with …

Stockholm, Sweden (Press Release) – CellProtect Nordic Pharma­ceu­ticals AB ('CPNP') has been notified by the Euro­pean Com­mis­sion that its cell ther­apy can­di­date CellProtect has re­ceived orphan drug desig­na­tion for the treat­ment of mul­ti­ple myeloma. CellProtect is manu­fac­tured from the patient's own blood and is the first drug can­di­date, con­sist­ing of au­tol­o­gous ex vivo activated and ex­panded nat­u­ral killer (NK) cells, which has re­ceived such desig­na­tion in Europe.

CPNP has carried out a clin­i­cal phase I/II trial in patients with mul­ti­ple myeloma where CellProtect has been studied as a supple­mental treat­ment to au­tol­o­gous stem …