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FDA Approved for RRMM: Darzalex (Daratumumab) + Kyprolis (Carfilzomib) and Dexamethasone (Dara-Kd)

Updated: Oct 19, 2021



On August 20, 2020, the Food and Drug Administration approved carfilzomib (KYPROLIS, Onyx Pharmaceuticals, Inc.) and daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.


The efficacy of carfilzomib and daratumumab with dexamethasone was evaluated in two clinical trials, CANDOR and EQUULEUS.


CANDOR (NCT03158688) was a randomized, open label, multicenter trial evaluating the combination of carfilzomib (20/56 mg/m2 twice weekly regimen) with intravenous daratumumab and dexamethasone (DKd) versus carfilzomib (20/56 mg/m2 twice weekly regimen) and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy. A total of 466 patients were randomized; 312 to the DKd arm and 154 to the Kd arm.


Efficacy was assessed by an independent review committee (IRC) evaluation of progression-free survival (PFS) using International Myeloma Working Group (IMWG) response criteria. Median PFS was not reached for the DKd arm and was 15.8 months (95% CI: 12.1, NE) for the Kd arm (HR 0.63; 95% CI: 0.46, 0.85; 1-sided p-value 0.0014).


EQUULEUS (NCT01998971) was an open label, multicohort trial evaluating the combination of carfilzomib (20/70 mg/m2 once weekly regimen) with intravenous daratumumab and dexamethasone (DKd). Efficacy was based on overall response rate (ORR) as assessed by IRC using IMWG response criteria. Of the 85 patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy enrolled in the DKd cohort, the ORR was 81% (95% CI: 71, 89) with a duration of response of 27.5 months (20.5, not estimable).


 

Learn more:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-carfilzomib-and-daratumumab-dexamethasone-multiple-myeloma


08/20/20: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761036Orig1s029ltr.pdf


https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202714Orig1s030ltr.pdf




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