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Takeda’s NINLARO fails to meet PFS primary endpoint in TOURMALINE-MM2 trial

Takeda’s NINLARO fails to meet PFS primary endpoint in TOURMALINE-MM2 trial

Takeda Pharmaceutical said that the Phase 3 TOURMALINE-MM2 trial in newly diagnosed multiple myeloma patients for NINLARO (ixazomib) in addition to lenalidomide and dexamethasone failed to meet the primary endpoint of progression-free survival (PFS). The late-stage trial assessed the combination of NINLARO (ixazomib) with lenalidomide and dexamethasone in comparison to lenalidomide and dexamethasone plus placebo […]

Janssen, Amgen secure FDA approval for DKd regiment in multiple myeloma

DKd regiment FDA approval for multiple myeloma : Janssen Pharmaceutical Companies of Johnson & Johnson and Amgen have been granted an expanded approval from the US Food and Drug Administration (FDA) for the DKd regimen comprising the former’s DARZALEX (daratumumab) and the latter’s Kyprolis (carfilzomib) plus dexamethasone for the treatment of multiple myeloma. The approval […]

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Cellectis begins MELANI-01 clinical trial for UCARTCS1 in multiple myeloma

Cellectis said that it has dosed the first patient in a phase 1  study – the MELANI-01 clinical trial to evaluate UCARTCS1, an allogeneic off-the-shelf CAR-T product candidate for the treatment of relapsed/refractory multiple myeloma (R/R MM). The French gene therapy company began the phase 1 dose-escalation study after getting clearance from the US Food […]

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CANDOR clinical trial results : Amgen’s Kyprolis extends PFS in multiple myeloma patients

CANDOR clinical trial results : Amgen said that a phase 3 study assessing Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson’s Darzalex (daratumumab) (KdD) compared to Kyprolis and dexamethasone alone (Kd), called CANDOR, met its primary endpoint of progression-free survival (PFS) in multiple myeloma patients. The Amgen clinical trial featured 466 relapsed or […]

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FDA approves new dosing option for Amgen blood cancer drug Kyprolis

The US Food and Drug Administration (FDA) has approved a weekly once dosing option for Amgen blood cancer drug Kyprolis (carfilzomib) in combination with dexamethasone (once-weekly Kd70) for patients having relapsed or refractory multiple myeloma. The prescribing information has been expanded to include a new weekly once dosing of 70 mg/m2 of KYPROLIS. Approval for […]

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Janssen bags EC approval for daratumumab for multiple myeloma

Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing authorization for its monoclonal antibody Darzalex (daratumumab) from the European Commission (EC) as initial therapy for adult patients with newly diagnosed multiple myeloma, who are not eligible for autologous stem cell transplant (ASCT). The EC approval is for the use of daratumumab in combination with […]

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