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Melphalan flufenamide - Oncopeptides

Drug Profile

Melphalan flufenamide - Oncopeptides

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

Latest Information Update: 16 Sep 2021

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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

  • 11 Sep 2021 The US FDA plans to schedule a Oncologic Drugs Advisory Committee (ODAC) meeting to discuss efficacy and safety results of Phase III OCEAN trial in Multiple myeloma in October 2021
  • 11 Sep 2021 Updated efficacy data from the phase III OCEAN trial in Multiple myeloma released by Oncopeptides AB
  • 27 Aug 2021 Clinical data from a phase III OCEAN trial in Multiple myeloma released by Oncopeptides
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