Oncopeptides withdraws multiple myeloma therapy from U.S. market
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The manufacturer of a drug that received FDA approval earlier this year for treatment of multiple myeloma has pulled the therapy from the U.S. market.
The decision came 3 months after the FDA alerted health care providers and patients about clinical trial results that showed increased mortality risk among patients who received the agent.
Melphalan flufenamide (Pepaxto, Oncopeptides) — an anticancer peptide-drug conjugate — uses technology that links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound.
The FDA in February granted accelerated approval to the agent in combination with dexamethasone for treatment of adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody.
Under terms of the accelerated approval, the agency required Oncopeptides to conduct the randomized phase 3 OCEAN trial.
The confirmatory OCEAN trial compared the combination of melphalan flufenamide and low-dose dexamethasone vs. pomalidomide (Pomalyst, Bristol Myers Squibb) and low-dose dexamethasone for patients with relapsed or refractory multiple myeloma who had received two to four prior lines of therapy and those who were resistant to lenalidomide (Revlimid, Bristol Myers Squibb) in their most recent line of therapy.
Results showed a detrimental effect on OS (HR = 1.104) among melphalan flufenamide-treated patients, prompting FDA to require the manufacturer to suspend enrollment of the OCEAN trial and other ongoing trials of the agent.
“The decision to withdraw Pepaxto from the market has been a difficult [one] that has been made with great consideration and with the best intentions for patients and shareholders,” Marty J. Duvall, CEO of Oncopeptides, said in a company-issued press release. “The company now needs to refocus its resources and energy on [research and development] and remain true to its mission of bringing hope to patients through science. We believe that this is the only viable path forward to accomplish this goal.”
The company remains confident in its scientific platform and will work with the FDA to ensure melphalan flufenamide is made available to patients who are receiving treatment, according to the release.
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