Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA), for the immuno­therapy DARZALEX®▼ (dara­tu­mu­mab). The appli­ca­tion seeks to broaden the existing mar­ket­ing authori­sa­tion to in­clude dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant.

“This sub­mission to health author­i­ties takes us one step closer to our goal of redefining com­bi­na­tion ther­apy in multiple myeloma, with the poten­tial to make dara­tu­mu­mab …

• Application to broaden label for dara­tu­mu­mab in front line multiple myeloma sub­mitted to EMA
• Submission based on data from Phase III ALCYONE study
• Genmab to receive USD 3 million in mile­stone pay­ments from Janssen

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation appli­ca­tion to the European Medicines Agency (EMA). This appli­ca­tion seeks to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude use in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone, for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­el­i­gible for au­tol­o­gous stem cell trans­plant (ASCT). The sub­mission of the appli­ca­tion triggers mile­stone …

Designations based on pre­lim­i­nary clin­i­cal data from on­go­ing phase I study of bb2121 in heavily pre-treated mul­ti­ple myeloma

Summit, NJ and Cambridge, MA (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) and bluebird bio, Inc. (NASDAQ:BLUE) to­day an­nounced that bb2121, a chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) ther­apy targeting b-cell maturation an­ti­gen (BCMA) in pre­vi­ously treated patients with mul­ti­ple myeloma, has been granted Break­through Therapy Desig­na­tion (BTD) by the U.S. Food and Drug Admin­istra­tion (FDA) and PRIority MEdicines (PRIME) eligibility by the Euro­pean Medicines Agency (EMA).

BTD desig­na­tion and PRIME eligibility for bb2121 were based on pre­lim­i­nary clin­i­cal data from the on­go­ing phase 1 study CRB-401. Updated data from CRB-401 is scheduled to be …

Madrid, Spain (Press Release) – Pursuant to article 228 of the restated text of the Securities Market Law, we hereby inform you of the fol­low­ing SIGNIFICANT EVENT:

Pharma Mar, S.A. announces that based on the pre­lim­i­nary feed-back (“trend vote”) from the European Medicines Agency (EMA) Com­mittee for Medicinal Products for Human Use (CHMP), the Company ex­pec­ts an Opinion recommending against approval of the Marketing Authorization Application (MAA) for Aplidin for the treat­ment of multiple myeloma submitted in October 2016. The formal written de­ci­sion from the CHMP is ex­pec­ted fol­low­ing its December 2017 meeting …

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced that it has re­ceived Break­through Therapy Desig­na­tion from the U.S. Food and Drug Admin­istra­tion (FDA) for GSK2857916 mono­­therapy in patients with mul­ti­ple myeloma who have failed at least three prior lines of ther­apy, in­­clud­ing an anti-CD38 anti­body and are re­frac­tory to a pro­te­a­some in­hib­i­tor and an immuno­modulatory agent. In Octo­ber, the Euro­pean Medicines Agency (EMA) granted PRIME desig­na­tion to GSK2857916 for the treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma patients whose prior ther­apy in­cluded a pro­te­a­some in­hib­i­tor, an immuno­modulatory agent …

Basel, Switzerland (Press Release) – Roche (SIX: RO, ROG; OTCQX: RHHBY): Based on emerging safety data from clin­i­cal trials eval­u­ating pembro­lizumab in com­bi­na­tion with either lena­lido­mide or poma­lido­mide in multiple myeloma, the FDA has requested that a Phase Ib and a Phase Ib/II TECENTRIQ study be placed on partial clin­i­cal hold. At Roche/Genentech we remain committed to patient safety and will con­tinue to work closely with the FDA. It is our under­stand­ing that the FDA is eval­u­ating all ongoing blood cancer trials investigating an anti-PD1/PDL1 medicine in com­bi­na­tion with an immuno­modu­latory medicine …

Summit, NJ (Press Release) –  Celgene Corpo­ra­tion (NASDAQ:CELG) today announced that the U.S. Food and Drug Admin­istration (FDA) has placed a partial clin­i­cal hold on five trials and a full clin­i­cal hold on one trial in the Celgene FUSION™ pro­gram. The trials are testing IMFINZI™ (durva­lumab), an anti-PD-L1 anti­body, in combi­nation with immuno­modulatory and chemo­therapy agents in blood cancers such as multiple myeloma, chronic lym­pho­cytic leukemia and lym­phoma.

The de­ci­sion by the FDA was based on risks identified in other trials for an anti-PD-1 anti­body, pem­bro­lizu­mab, in patients with multiple myeloma in …