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Oncopeptides

FDA warns on increased risk of death with Pepaxto for multiple myeloma

July 28, 2021 By Sean Whooley

Oncopeptides

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Immunotherapy, Oncology, Pharmaceuticals Tagged With: FDA, Oncopeptides

Oncopeptides completes enrollment in Phase 2 multiple myeloma study

May 5, 2021 By Sean Whooley

Oncopeptides

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Immunotherapy, Oncology, Pharmaceuticals Tagged With: Oncopeptides

Oncopeptides seeks EU marketing authorization for multiple myeloma treatment

April 16, 2021 By Sean Whooley

Oncopeptides

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 […]

Filed Under: Featured, Oncology, Pharmaceuticals Tagged With: Oncopeptides

Oncopeptides launches Pepaxto multiple meyeloma treatment

March 15, 2021 By Sean Whooley

Oncopeptides

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 […]

Filed Under: Business/Financial News, Featured, Oncology, Pharmaceuticals Tagged With: Oncopeptides

FDA approves Oncopeptides treatment for multiple myeloma

March 1, 2021 By Sean Whooley

Oncopeptides

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 […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Oncology, Regulatory/Compliance Tagged With: FDA, Oncopeptides

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