The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R Multiple Myeloma

August 21, 2020 Auto Bot daratumumab, DARZALEX, FDA, Uncategorized 0

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 ­to­ read full press release/ article | Ref: Janssen, Amgen  | Image: Revlimid