The CHMP adopted two pos­i­tive opinions recommending European Com­mis­sion approval of:

• REVLIMID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (RVd) in adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant
• IMNOVID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), for adult patients with multiple myeloma, who have received at least one prior treat­ment regi­men in­­clud­ing lena­lido­mide

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted pos­i­tive opinions for two triplet regi­mens based on Celgene’s pro­pri­e­tary IMiD® medications, REVLIMID (lena­lido­mide) and IMNOVID (poma­lido­mide).

The CHMP recommended approval of an expanded indi­ca­tion of REVLIMID as com­bi­na­tion ther­apy with bor­tez­o­mib and dexa­meth­a­sone (RVd) for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant.

The committee also recommended approval …

First DARZALEX com­bi­na­tion treat­ment regi­men being pursued in the frontline setting for trans­plant eli­gible patients with multiple myeloma

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) for newly diag­nosed patients with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The Phase 3 CASSIOPEIA (MMY3006) clin­i­cal study, which sup­ports the sBLA sub­mission, met its pri­mary end­point – the proportion of patients that achieved stringent Complete Response (sCR) after in­duction and con­sol­i­da­tion …

• sBLA submitted to U.S. FDA for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc., has submitted a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTD) as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). In August 2012, Genmab granted Janssen an exclusive world­wide license to develop, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab. …

Application sup­ported by the Phase 3 MAIA study for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eligible for au­tol­o­gous stem cell trans­plant

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA) for DARZALEX®▼ (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

“Today’s sub­mission brings us one step closer to our goal of im­prov­ing treat­ment out­comes for people newly diag­nosed with multiple myeloma,” said José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and …

• Type II variation appli­ca­tion submitted to the EMA for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed multiple myeloma patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III MAIA study

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). The appli­ca­tion seeks to broaden the existing mar­ket­ing authori­za­tion for dara­tu­mu­mab (DARZALEX®) to in­clude use in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for newly diag­nosed multiple myeloma patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The sub­mission is based on data from the Phase III …

Milan, Italy (Press Release) – MolMed S.p.A. (MLMD.MI), a bio­technology com­pany focused on research, devel­op­ment, pro­duc­tion and clin­i­cal val­i­da­tion of gene and cell ther­a­pies for the treat­ment of cancer and rare diseases, announces to have obtained the authori­za­tion from AIFA to start phase I-II first in man clin­i­cal trials with its own CAR-T CD44v6 for the treat­ment of patients with acute myeloid leukemia (AML) and multiple myeloma (MM). The authori­za­tion from AIFA follows the positive tech­ni­cal opinion expressed by the Italian National Institute of Health – ISS (Istituto Superiore di Sanità) on March …

Shanghai, China (Press Release) – I-Mab Bio­pharma (I-Mab), a China-based clin­i­cal stage bio­pharma­ceu­tical com­pany ex­clu­sively focused on the devel­op­ment of inno­va­tive biologics in immuno-oncology and auto­immune dis­eases, and German biopharma com­pany MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;NASDAQ: MOR), to­day an­nounced that the first patient dosing (FPD) has been achieved in a phase 2 multi-center clin­i­cal study in Taiwan to eval­u­ate an inves­ti­ga­tional human CD38 anti­body TJ202 / MOR202 in patients with re­lapsed or re­frac­tory multiple myeloma. TJ202 / MOR202 is an anti­body devel­oped by MorphoSys AG. I-Mab owns the ex­clu­sive …