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FDA approves Oncopeptides' PEPAXTO ( melphalan flufenamide) for patients with relapsed or refractory multiple myeloma

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. ....

United States , United Kingdom , Martyj Duvall , Anders Martin , Ola Landgren , Rolf Gulliksen , Klaas Bakker , Linda Holmstr , Jakob Lindberg , Leader Of Experimental Therapeutics Program , Myeloma Program , Sylvester Comprehensive Cancer Center , Drug Administration , Global Head Of Corporate Communications , University Of Miami Health System In , Division Of Hematology , Nasdaq Stockholm , Chief Executive Officer , New Drug Application , Chief Scientific Officer , Professor Ola Landgren , Experimental Therapeutics Program , Miami Health System , Overall Response Rate , Median Duration , Extra Medullary Disease ,

FDA approves Oncopeptides' PEPAXTO® ( melphalan flufenamide) for patients with relapsed or refractory multiple myeloma

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.

United States , United Kingdom , Martyj Duvall , Anders Martin , Ola Landgren , Rolf Gulliksen , Klaas Bakker , Linda Holmstr , Jakob Lindberg , Leader Of Experimental Therapeutics Program , Myeloma Program , Sylvester Comprehensive Cancer Center , Drug Administration , Global Head Of Corporate Communications , Miami Health System In , Division Of Hematology , Nasdaq Stockholm , Chief Executive Officer , New Drug Application , Chief Scientific Officer , Professor Ola Landgren , Experimental Therapeutics Program , Miami Health System , Overall Response Rate , Median Duration , Extra Medullary Disease ,

Oncopeptides enrolls the first patient in the phase 3 LIGHTHOUSE combination study in multiple myeloma

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. ....

United States , Klaas Bakker , Linda Holmstr , Drug Administration , Nasdaq Stockholm , Chief Medical Officer , Director Investor Relations , Senior Advisor Investor Relations , Adverse Events , New Drug Application , Mid Cap , ஒன்றுபட்டது மாநிலங்களில் , கிளாஸ் பேக்கர் , நாஸ்டாக் ஸ்டாக்‌ஹோல்ம் , தலைமை மருத்துவ அதிகாரி , இயக்குனர் முதலீட்டாளர் உறவுகள் , புதியது மருந்து விண்ணப்பம் , நடுவில் தொப்பி ,

Full data set of Oncopeptides phase 2 HORIZON study in multiple myeloma published in the Journal of Clinical Oncology

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: [email protected]
E-mail: [email protected]
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 overexpre ....

United States , Klaas Bakker , Drug Administration , Nasdaq Stockholm , New Drug Application , Chief Medical Officer , Class Refractory , Medullary Disease , Response Rate , Progression Free Survival , Overall Survival , Investor Relations , Adverse Events , Mid Cap , Clinical Oncology , ஒன்றுபட்டது மாநிலங்களில் , கிளாஸ் பேக்கர் , நாஸ்டாக் ஸ்டாக்‌ஹோல்ம் , புதியது மருந்து விண்ணப்பம் , தலைமை மருத்துவ அதிகாரி , வர்க்கம் பயனற்ற , பதில் ரேட் , ப்ரோக்ரெஶந் இலவசம் பிழைப்பு , ஓவரால் பிழைப்பு , முதலீட்டாளர் உறவுகள் , நடுவில் தொப்பி ,