The FDA today issued a notice warning patients and healthcare professionals of a potentially increased risk of death with Pepaxto. Pepaxto (melphalan flufenamide), used with dexamethasone to treat patients with multiple myeloma, demonstrated an increased risk of death in the OCEAN clinical trial. The FDA required that the manufacturer, Boston-based Oncopeptides (STO:ONCO) suspend enrollment for […]
Oncopeptides
Oncopeptides completes enrollment in Phase 2 multiple myeloma study
Oncopeptides announced today that it completed patient enrollment for its Phase 2 Port study of its multiple myeloma treatment. Waltham, Mass.-based Oncopeptides’ Port study is an open-label, randomized, crossover study comparing the safety, tolerability and efficacy of peripheral or central intravenous administration of Pepaxto (melphalan flufenamide) in combination with dexamethasone to treat relapsed refractory multiple […]
Oncopeptides seeks EU marketing authorization for multiple myeloma treatment
Oncopeptides announced today that it submitted an application for European marketing authorization of its melflufen therapeutic. Conditional marketing authorization from the European Medicines Agency (EMA) is the aim for the company after its pivotal phase 2 Horizon study provided positive outcomes with melflufen (melphalan flufenamide) in treating relapsed refractory multiple myeloma, according to a news […]
Oncopeptides launches Pepaxto multiple meyeloma treatment
Oncopeptides (STO:ONCO) announced today that it launched its Pepaxto drug for treating relapsed or refractory multiple myeloma. Boston-based Oncopeptides’ Pepaxto (melphalan flufenamide), which received accelerated FDA approval on Feb. 26, is now commercially available and the first patients are being treated with the drug, according to a news release. Pepaxto received approval in combination with […]
FDA approves Oncopeptides treatment for multiple myeloma
Oncopeptides (STO:ONCO) announced today that it received FDA approval for its Pepaxto treatment for multiple myeloma. Waltham, Mass.-based Oncopeptides’ Pepaxto (melphalan flufenamide) received approval in combination with dexamethasone for treating 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 […]
