The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R Multiple Myeloma
Shots:
- The US FDA has approved Janssen’s Darzalex + Amgen’s Kyprolis (carfilzomib) and dexamethasone (DKd) in two dosing regimen (70 mg/m2 - qw and 56 mg/m2 - q2w) for the treatment of adult patients with r/r MM who have received 1-3L therapies
- The approval of q2w dosing regimen is based on P-III CANDOR study assessing DKd (q2w) vs Kd in 466 patients with r/r MM and has met its 1EPs of PFS after a median follow-up of 16.9 & 16.3 mos. respectively
- The inclusion of carfilzomib (qw) as an approved DKd regimen is based P-Ib EQUULEUS study assessing Darzalex in combination with multiple treatment regimens. Carfilzomib (qw) was evaluated with a starting dose of 20 mg/m2- which was increased to 70 mg/m2 on Cycle 1- Day 8 and onward
Source 1- Source 2 Ref: Janssen- Amgen | Image: Revlimid
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