Articles tagged with: Relapsed Multiple Myeloma
Press Releases»

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the US Food and Drug Administration, FDA, has granted priority review for Oncopeptides' New Drug Application seeking approval of melflufen (INN melphalan flufenamide), in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients). The FDA has set a PDUFA-date (Prescription Drug User Fee Act), which is the target date for their review …
Press Releases»
- BLENREP is the first anti-BCMA (B-cell maturation antigen) therapy approved in the European Union
- Marketing authorisation follows the recent US approval of BLENREP
London, United Kingdom (Press Release) – GlaxoSmithKline plc today announced the European Commission has granted conditional marketing authorisation for BLENREP (belantamab mafodotin) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. BLENREP is a first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose …
Press Releases»
Approval broadens DARZALEX label to include fifth treatment option in the relapsed / refractory setting and represents the eighth approved indication for DARZALEX
Horsham, PA (Press Release) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for the treatment of adult patients with relapsed / refractory multiple myeloma who have received one to three previous lines of therapy. DARZALEX® has been approved in combination with two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS studies, representing the first-ever approval of an …
Press Releases»
- DARZALEX® (daratumumab) approved by U.S. FDA in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed / refractory multiple myeloma who have received one to three previous lines of therapy
- Approval based on the Phase 3 CANDOR study
- Approval marks eighth U.S. FDA approval for DARZALEX
Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX® (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adult patients with relapsed / refractory multiple myeloma who have received one to three previous lines of therapy. A supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen), in February 2020. In August 2012, Genmab granted …
Press Releases»
- BLENREP is a first-in-class anti-BCMA (B-cell maturation antigen) therapy for patients whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody
- BLENREP is the fifth major medicine approval for GSK in 2020
London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in …
Press Releases»

Lund, Sweden (Press Release) – Active Biotech (NASDAQ STOCKHOLM: ACTI) today announces that the first patient has been dosed in the phase 1b/2a clinical study of tasquinimod for treatment of relapsed or refractory multiple myeloma. The study, which is planned to recruit up to 54 patients, will establish a maximum tolerated dose of tasquinimod as single agent and then investigate tasquinimod in combination with a standard multiple myeloma oral regimen of ixazomib, lenalidomide, and dexamethasone (IRd). For both single agent tasquinimod and the combination of tasquinimod and IRd, exploratory expansion cohorts will be …
Press Releases»
- Phase 3 APOLLO randomized study evaluating subcutaneous daratumumab in combination with pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in relapsed or refractory multiple myeloma met the primary endpoint of improving progression-free survival
- Janssen intends to discuss the data with health authorities for potential regulatory submissions
Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) announced today that the European Myeloma Network (EMN) in collaboration with Janssen Research & Development, LLC (Janssen) reported positive results from the Phase 3 APOLLO (MMY3013) study of the subcutaneous (SC) formulation of daratumumab in combination with pomalidomide and dexamethasone (Pd) versus Pd alone as treatment for patients with relapsed or refractory multiple myeloma who have previously been treated with lenalidomide (an immunomodulatory drug) and a proteasome inhibitor (PI). The study met the primary …