2022-08-19| Trials & Approvals

Oncopeptides’ Pepaxti Won EMA Approval for Multiple Myeloma

by Nai Ye Yeat
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) signed off full marketing approval for Oncopeptides’ new drug, Pepaxti on 18 Aug. 

As a third-line treatment for relapsed refractory multiple myeloma patients in Europe, the company expects 10,000 patients to be treated annually.

Related article: Janssen’s First Cell Therapy Gets Europe’s Approval for Multiple Myeloma

Current Profile of Multiple Myeloma

Multiple myeloma is cancer that originates in plasma cells (a type of white blood cells that produce antibodies to fight infection) and causes cancer cells to accumulate in the bone marrow. As the second most common hematologic malignancy, multiple myeloma accounts for approximately 1-2% of all new cancer cases, with a global incidence rate of 1.7 per 100,000. An estimated 35,842 patients were diagnosed in 27 European Union countries during 2020, with an estimated 23,275 deaths due to the disease.

As the disease progresses, patients may become refractory to all available treatment options due to mutations and clonal evolution of the tumor cells. These patients usually have a very short expected overall survival, and there is no cure for multiple myeloma available currently, while the ongoing research mainly focused on relapse management. 

Once Withdrawal Due to Safety Issue

During the same period last year, the company voluntarily pulled Pepaxto (original name of Pepaxti) from the market as soon as the FDA issued a warning about its safety based on early results of a required confirmatory trial. The phase 3 Ocean study showed that patients treated with Pepaxto and the steroid dexamethasone had a 10% higher risk of death than those who receive Bristol Myers Squibb’s Pomalyst plus dexamethasone.

Oncopeptides’ stock price was promptly slumped and forced to undergo a radical restructure after the incident.

On the other hand, the EMA has a different perspective of viewing the data from the same trial and concluded that the overall survival results in the Ocean study constitute a case of true survival heterogeneity. Also, there are no toxicological safety signals and a positive benefit-risk profile in the indicated patient population.

Pepaxti is believed to become a new option for triple-class refractory patients, who have received at least three prior lines of therapies, and is refractory to immunomodulatory drugs, proteasome inhibitors, and CD38- targeting monoclonal antibodies.


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