FDA approval sought for once-weekly carfilzomib

Amgen have submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA), for once-weekly dosing of carfilzomib (Kyprolis®) in combination with dexamethasone, in patients with relapsed and refractory multiple myeloma (RRMM).

The application was based on data from the phase III ARROW study, presented by Maria-Victoria Mateos at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting – read here and listen here. The study was conducted in collaboration with Philippe Moreau from the University Hospital of Nantes, Nantes, France, and was published in The Lancet Oncology on 1 June 2018.

In this trial, carfilzomib was administered at a dose of 70 mg/m2 once-weekly (along with dexamethasone), instead of the usual twice-weekly dose of 27 mg/m2. The study showed that patients receiving the once-weekly dosing had a median progression-free survival (PFS) of 11.2 months compared to 7.6 months for twice-weekly dosing. In addition, the overall response rate (ORR) in patients in the once-weekly arm was 62.9% (95% CI, 56.5-69.0), with 7% of patients also achieving a complete response or better, compared to an ORR of 40.8% (95% CI, 35.5-47.3) in the twice-weekly arm (P <.0001) and only 2% of patients in this arm achieving a CR. There was only a moderate increase in grade 3 (or greater) adverse events (68% vs 62%) for the once-weekly compared to twice-weekly, with complaints including anemia, pneumonia, diarrhea, and thrombocytopenia.

Given that this new regimen offers both improved efficacy and improved convenience for patients, there will be many people eagerly awaiting approval.

  1. https://www.targetedonc.com/news/onceweekly-carfilzomib-submitted-for-fda-approval-in-myeloma
  2. Moreau P. et al. Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. The Lancet Oncology. June 2018. DOI:https://doi.org/10.1016/S1470-2045(18)30354-1
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