Articles tagged with: Kyprolis
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 …
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Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced that the U.S. District Court in Delaware issued a decision upholding the validity of patent claims from three patents that protect Amgen's multiple myeloma therapy KYPROLIS® (carfilzomib). Today's decision will prevent Cipla Limited, and Cipla USA, Inc. (collectively "Cipla") from making, using, selling, offering to sell, or importing its generic version of KYPROLIS until expiration of these three U.S. patents. The latest patent expiry is in December 2027.
Onyx Therapeutics, Inc., an indirect, wholly-owned subsidiary of Amgen Inc., brought a patent infringement suit …
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Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting
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 Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed / refractory multiple myeloma. The sBLA is supported by results from the Phase 3 CANDOR study, which compared treatment with DKd to carfilzomib and dexamethasone (Kd) in patients with multiple myeloma who relapsed after one to three prior lines of therapy.
"While we continue to …
Press Releases»
- Phase III CANDOR study of daratumumab in combination with carfilzomib and dexamethasone in relapsed or refractory multiple myeloma met the primary endpoint of improvement in progression free survival
- Data to be discussed with health authorities in preparation for regulatory submissions
Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today topline results from the Phase III CANDOR study, sponsored by Amgen, of daratumumab in combination with carfilzomib and dexamethasone (Kd) versus Kd alone in patients with multiple myeloma who have relapsed after one to three prior therapies. The study met the primary endpoint of improving progression free survival (PFS). The regimen resulted in a 37% reduction in the risk of progression or death in patients with relapsed or refractory multiple myeloma treated with …
Press Releases»
First Phase 3 Study Combining KYPROLIS and DARZALEX, Two Critical Mechanisms of Action in Treatment of Multiple Myeloma
Thousand Oaks, CA (Press Release) -- Amgen (NASDAQ:AMGN) today announced the Phase 3 CANDOR study evaluating KYPROLIS® (carfilzomib) in combination with dexamethasone and DARZALEX® (daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone (Kd) met its primary endpoint of progression-free survival (PFS). The regimen resulted in a 37% reduction in the risk of progression or death in patients with relapsed or refractory multiple myeloma treated with KdD (HR=0.630; 95% CI: 0.464, 0.854; p=0.0014). The median PFS for patients treated with Kd alone was 15.8 months, while the median PFS for patients treated …
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Ein Team von US-Forschern hat die Ergebnisse einer Untersuchung von Augenlidkomplikationen bei Patienten mit multiplem Myelom veröffentlicht, die mit Velcade oder Kyprolis behandelt wurden. Auf Grundlage ihrer Untersuchungsergebnisse schlagen die Autoren der neuen Studie auch Leitlinien für die Prävention und das Management solcher Komplikationen vor.
Die Autoren berichten über eine Fallserie von 16 Patienten, die nach Beginn der Behandlung mit Velcade (Bortezomib) oder Kyprolis (Carfilzomib) entweder Blepharitis oder ein Hagelkorn entwickelten.
Blepharitis ist der medizinische Begriff für chronische Entzündungen des Augenlids; ein Hagelkorn (Chalazion) ist eine Zyste im Augenlid, die durch eine …