Vincent Rajkumar, Professor of Medicine at the Mayo Clinic in Rochester and Editor‑in‑Chief at Blood Cancer Journal, shared a post on X:
“Historic and Paradigm Changing:
FDA approves daratumumab for high-risk smoldering multiple myeloma based on the AQUILA trial – the FIRST ever treatment approved for this indication.
Excellent news and thanks to J&J Innovative Medicine and the huge worldwide team of investigators for making it happen.
Daratumumab was earlier approved for high-risk smoldering myeloma in Europe based on the same trial.
Details of this paradigm-changing trial. Trial published in NEJM Dec 2024 to coincide with ASH presentation.
EU approval was in July. I’m really glad to have FDA approval. This is just huge news for the field. And for patients.”
Title: Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma
Authors: M.A. Dimopoulos, P.M. Voorhees, F. Schjesvold, Y.C. Cohen, V. Hungria, I. Sandhu, J. Lindsay, R.I. Baker, K. Suzuki, H. Kosugi, M.-D. Levin, M. Beksac, K. Stockerl-Goldstein, A. Oriol, G. Mikala, G. Garate, K. Theunissen, I. Spicka, A.K. Mylin, S. Bringhen, K. Uttervall, B. Pula, E. Medvedova, A.J. Cowan, P. Moreau, M.-V. Mateos, H. Goldschmidt, T. Ahmadi, L. Sha, A. Cortoos, E.G. Katz, E. Rousseau, L. Li, R.M. Dennis, R. Carson, and S.V. Rajkumar, for the AQUILA Investigators
You can read the Full Article in The New England Journal of Medicine.
You can find more posts featuring Vincent Rajkumar on OncoDaily.