Drugs and Medicinal Substances

Melphalan flufenamide

Antineoplastic and Immunomodulating Agents

Melphalan flufenamide, sold under the brand names Pepaxto and Pepaxti, is a medication for treating refractory multiple myeloma, available in multiple European countries but not in the United States. It is an alkylating agent that functions as a peptidase enhanced cytotoxic, delivering the alkylating agent melphalan in a targeted way within tumor cells. It is given intravenously. In the United States before its withdrawal it was indicated for adults with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy and were refractory to proteasome inhibitors, immunomodulatory agents and CD-38 monoclonal antibodies, while the European Union indication requires at least three prior therapy lines. It received FDA approval in February 2021, was withdrawn from the United States market in October 2021, and received European Union approval in August 2022.

Facts
Approved Use
In combination with dexamethasone for the treatment of patients with multiple myeloma 4
First Approved / Isolated Year
2021 5
Significant Risk
Not shown to be safe or effective under its conditions of use; the confirmatory OCEAN trial did not confirm clinical benefit 4
Classification
Approval Status
Approved 1
ATC ClassSourced to the subject's own account
L: Antineoplastic and Immunomodulating Agents 2
Route of Administration
Intravenous 3
Connections

Long-Form Articles

Sources
1. Melphalan flufenamide (Wikipedia)
Lead section, approval-status statement
Quote, Lead section, approval-status statement
Melphalan flufenamide was approved for medical use in the United States in February 2021, and in the European Union in August 2022.
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code L
Quote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
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3. Melphalan flufenamide (Wikipedia)
WikipediaInfobox drug, routes_of_administration
Quote, Infobox drug, routes_of_administration
Intravenous
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4. FDA Confirms Decision to Withdraw Melphalan Flufenamide Approval in Multiple Myeloma
  • Body, indication sentence
    for use in combination with dexamethasone for the treatment of patients with multiple myeloma
  • Body, reason for withdrawal
    has not been shown to be safe or effective under its conditions of use
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5. Drugs.com: Pepaxto (melphalan flufenamide) FDA Approval History
FDA Approval History
Quote, FDA Approval History
FDA granted accelerated approval to melphalan flufenamide (Pepaxto) on February 26, 2021
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