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Melphalan flufenamide - Oncopeptides

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Drug Profile

Melphalan flufenamide - Oncopeptides

Alternative Names: CK-1535; J 1; Mel-flufen; Melphalan flufenamide hydrochloride - Oncopeptides; Melphalan-prodrug-Oncopeptides; Pepaxti; PEPAXTO; Ygalo

Latest Information Update: 29 Mar 2024

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At a glance

  • Originator Oncopeptides
  • Class Amides; Amines; Antineoplastics; Chlorinated hydrocarbons; Esters; Fluorobenzenes; Peptide drug conjugates
  • Mechanism of Action Alkylating agents
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Multiple myeloma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Multiple myeloma
  • Phase I/II Amyloid light-chain amyloidosis
  • Preclinical Acute myeloid leukaemia; Breast cancer; Diffuse large B cell lymphoma
  • Discontinued Cancer

Most Recent Events

  • 27 Mar 2024 Oncopeptides enters into an exclusive distribution agreement with Vector Pharma to commercialize melphalan flufenamide in MENA countries of Saudi Arabia, Qatar, UAE, Bahrain, Kuwait, Oman, Algeria, Tunisia, Morocco, Libya, Lebanon, and Iraq
  • 30 Jan 2024 Oncopeptides terminates a phase III OCEAN trial for Multiple myeloma (Combination therapy, Second-line therapy or greater) in Hungary, Spain, the Czech Republic, United Kingdom, Greece, Belgium, Denmark, Netherlands, Poland, Norway, USA, France, Israel, Austria, Estonia, Lithuania, South Korea, Romania, Russia, Taiwan and Italy (IV) after assessing all endpoints and collecting Overall Survival data for an additional two years (NCT03151811) (EudraCT2016-003517-95)
  • 09 Dec 2023 Efficacy and adverse events data from the phase III OCEAN trial in multiple myeloma presented at the 65th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2023)
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