Darzalex catches Sarclisa

Johnson & Johnson and Genmab’s Darzalex has cancelled out any advantage held by Sanofi’s rival anti-CD38 MAb Sarclisa, with a new front-line multiple myeloma approval. Subcutaneous Darzalex got the US nod on Tuesday for transplant-ineligible patients, in combination with Velcade, Revlimid and dexamethasone (VRd), based on the Cepheus trial – a setting that saw a complete response letter last year over manufacturing issues. Sarclisa, also alongside VRd, has been FDA approved here since 2024, based on the Imroz trial. Notably, Imroz had a traditional primary endpoint, progression-free survival, while Cepheus primarily assessed minimal residual disease negativity; the latter is becoming increasingly accepted by the FDA in earlier therapy lines. Meanwhile, Darzalex plus VRd is ahead in first-line transplant-eligible myeloma, where it got the US nod in 2024 based on Perseus; Sarclisa plus VRd isn’t yet FDA approved here, but got an EU go-ahead last year based on the first part of an investigator-sponsored trial, GMMG-HD7. Darzalex is well ahead in terms of sales, hitting $14.4bn in 2025, while Sarclisa brought in €471m in 2024. Sanofi will hope that approval of subcutaneous Sarclisa will bolster revenues; an FDA decision is due in April, backed by the Iraklia study.

Darzalex vs Sarclisa in early multiple myeloma

Note: *investigator-sponsored trial. Source: OncologyPipeline.