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 is for two dosing regimens of the DKd combination therapy, to be given 70 mg/m2 weekly once and 56 mg/m2 weekly thrice for multiple myeloma in relapsed or refractory forms (R/R MM) in patients who had been subjected to one to three previous lines of therapy.
David M. Reese – executive vice president of Amgen Research and Development, commenting on the DKd regiment FDA approval for multiple myeloma, said: “This expanded approval for KYPROLIS demonstrates a leap forward in the treatment paradigm for this complex disease by combining two potent agents in their respective drug classes indicated for patients with relapsed or refractory multiple myeloma.”
The DKd regiment FDA approval for multiple myeloma is based on the phase 3 CANDOR and phase 1b EQUULEUS clinical trials in patients having relapsed/refractory multiple myeloma.
The CANDOR trial, which was the first phase 3 randomized trial that compared the DKd regimen versus Kyprolis and dexamethasone (Kd) alone in 466 R/R MM patients, met its primary endpoint of progression-free survival (PFS). The late-stage clinical trial showed that the DKd regimen delivered a reduction of 37% in the risk of disease progression or death in patients in comparison to the combination of Kyprolis and dexamethasone.
The approval of the once-weekly dosing of Kyprolis as an approved DKd regimen was supported by positive results from the open label, multi-cohort EQUULEUS clinical trial, which evaluated DARZALEX in combination with various treatment regimens.
Craig Tendler – Janssen Research & Development Vice President, Late Development and Global Medical Affairs, said: “With this most recent approval of the DKd regimen, patients with multiple myeloma now have the option to receive treatment with DARZALEX and carfilzomib as early as their first relapse, which is a critical time in their treatment journey.
“With our deep disease focus and commitment to develop regimens which can help improve patient outcomes for patients with relapsed multiple myeloma, the CANDOR study further establishes another DARZALEX-containing regimen (DKd) which may provide benefit for this patient population.”