With New Data, Oncopeptides Rescinds Pepaxto Withdrawal

Three months after Oncopeptides AB said it was voluntarily withdrawing Pepaxto (melphalan flufenamide) from the U.S. market, the company is now taking back that withdrawal and has begun working with the FDA to review new data on the multiple myeloma therapy.

On Jan. 21, the company said that it had contacted the FDA to rescind its Oct. 22 letter requesting voluntary withdrawal of the agent’s New Drug Application (NDA). According to a company press release, “further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials have led the Company to reconsider its previous voluntary withdrawal request. Oncopeptides has discontinued the marketing of Pepaxto in the US and does not intend to market Pepaxto in the US at this time. The company has initiated a dialogue with the FDA to review the new data.”

Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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