FDA approves Oncopeptides PEPAXTO ( melphalan flufenamide) for patients with relapsed or refractory multiple myeloma
STOCKHOLM, Feb. 26, 2021 /PRNewswire/ Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO
), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug Administration, FDA, has approved PEPAXTO (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
FDA approves Oncopeptides PEPAXTO® ( melphalan flufenamide) for patients with relapsed or refractory multiple myeloma prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
Oncopeptides enrolls the first patient in the phase 3 LIGHTHOUSE combination study in multiple myeloma
STOCKHOLM, Dec. 21, 2020 /PRNewswire/ Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), today announced that the first patient has been dosed in the phase 3 LIGHTHOUSE study, evaluating the efficacy and safety of a triple combination therapy with melflufen plus dexamethasone and subcutaneous daratumumab compared to daratumumab alone. The phase 3 LIGHTHOUSE study is a randomized, open-label study in patients with relapsed refractory multiple myeloma who are refractory to an immunomodulatory agent and a proteasome inhibitor or who have had at least three prior lines of therapy, including these agents.
Full data set of Oncopeptides phase 2 HORIZON study in multiple myeloma published in the Journal of Clinical Oncology
Triple Class Refractory (n=119)
Extra Medullary Disease (n=55)
Overall Response Rate (ORR)
4.2 months
5.5 months
8.5 months
For more information, please contact:
Klaas Bakker, MD, PhD, Chief Medical Officer, Oncopeptides
Mail: klaas.bakker@oncopeptides.com
E-mail: rein.piir@oncopeptides.com
Cell phone: +46 70 853 72 92
The information in this press release was submitted for publication on December 9, 2020 at 22:00 (CET).
About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronoun