FDA nod for Kyprolis combo with Darzalex and DKd

The US Food and Drug Administration has approved the expansion of the Kyprolis (carfilzomib) US prescribing information to include its use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy.

"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," said Dr David Reese, executive vice president of R&D at Amgen (Nasdaq: AMGN).

"Now, we can provide healthcare professionals and patients with an efficacious regimen with two dosing options at a critical time in a patient's treatment journey: first relapse," Dr Reese continued.