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    Association details:
    Biomarker:No biomarker
    Cancer:Multiple Myeloma
    Drug:Melflufen (melphalan flufenamide) (Alkylating agent)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Oncopeptides Press Release
    Title:

    European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma

    Published date:
    08/18/2022
    Excerpt:
    Oncopeptides AB...today announces that the European Commission has granted Pepaxti (melphalan flufenamide, also called melflufen) marketing authorization in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    ESMO.org
    Title:

    Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

    Published date:
    02/03/2021
    Excerpt:
    Recommendations: HDM (200 mg/m2) is the standard conditioning regimen before ASCT [I, A].
    DOI:
    10.1016/j.annonc.2020.11.014
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Myeloma Therapy...Therapy for previously treated multiple myeloma...Other Recommended Regimens: melphalan flufenamide /dexamethasone
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASH 2023
    Title:

    2018 Long-Term Outcomes from the Phase 3 OCEAN (OP-103) Study: Melflufen and Dexamethasone (Dex) Versus Pomalidomide (Pom) and Dex in Relapsed Refractory Multiple Myeloma (RRMM)

    Published date:
    11/02/2023
    Excerpt:
    This long-term follow-up of OCEAN confirms the favorable safety and OS outcomes of melflufen + dex in the target population and supports its continued use as an alternative treatment choice for pts with RRMM who have received ā‰„2 prior LoT and who have not received ASCT.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Oncopeptides Press Release
    Title:

    Phase 3 OCEAN study demonstrates that melflufen is at least as efficacious as pomalidomide, the most used medicine in relapsed refractory multiple myeloma

    Published date:
    05/25/2021
    Excerpt:
    Oncopeptides AB...announces positive topline results from the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) versus pomalidomide in patients with relapsed refractory multiple myeloma (RRMM)...the median PFS for the melflufen arm was more than 40% higher than for the pomalidomide arm. The Overall Response Rate for melflufen was 32.1% vs. 26.5% for pomalidomide.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Oncopeptides Press Release
    Title:

    FDA grants Priority Review of melflufen for patients with triple-class refractory multiple myeloma

    Published date:
    08/29/2020
    Excerpt:
    Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the US Food and Drug Administration, FDA, has granted priority review for OncopeptidesĀ“ New Drug Application seeking approval of melflufen (INN melphalan flufenamide), in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients).