Biotech Business - January 24, 2022
Oncopeptides rescinds voluntary withdrawal of Pepaxto in the US
The company has contacted the US Food and Drug Administration and rescinded the October 22, 2021, letter requesting voluntary withdrawal of the NDA of Pepaxto (INN melphalan flufenamide, also called melflufen) in the US. Further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials have […]
Clinical Trials - January 20, 2022
Oncopeptide study published in the Lancet
Data from the phase 3 OCEAN study, evaluating the efficacy and safety of melflufen plus dexamethasone versus pomalidomide plus dexamethasone in lenalidomide refractory patients with relapsed refractory multiple myeloma that have received 2-4 prior lines of therapy, have been published in the Lancet Hematology. The OCEAN study was initiated in 2017 and includes 495 patients […]
In a new job - November 15, 2021
He is the new CEO of Oncopeptides
The Board of Directors has appointed Jakob Lindberg as Chief Executive Officer, CEO of Oncopeptides. Jakob Lindberg replaces Marty J Duvall, who has been the CEO since July 1, 2020. These changes are effective immediately. Returns to being a Sweden based R&D company The leadership changes follows the withdrawal of Pepaxto (INN melphalan flufenamide) from […]
In a new job - November 9, 2021
Oncopeptides appoints new interim CFO
Oncopeptides has appointed Annika Muskantor as interim Chief Financial Officer, CFO. Muskantor has an extensive experience as interim CFO from a broad range of industries including the life science industry, and she assumed her position on November 8. The appointment follows the previously announced resignation by CFO Anders Martin-Löf. Photo: iStock
Biotech Business - November 6, 2021
Oncopeptides reduces the activity level in the development program of melflufen
Oncopeptides has decided to reduce the activity level in the clinical development program with melflufen (INN melphalan flufenamide) to increase the company’s cash runway and at the same time support the ongoing marketing authorization application process in Europe. This will have implications on the following studies: OCEAN study will continue with long-term follow-up and documentation […]
Pharma Business - October 23, 2021
Oncopeptides withdraws Pepaxto in the US and scales down its organization
Oncopeptides has announced that the company has decided to withdraw Pepaxto (INN melphalan flufenamide) from the market in the US, following the phase 3 OCEAN study, which showed an overall survival in the ITT population with a HR of 1.104. The decision has been made after interactions and dialogue with the US Food and Drug […]
