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Accelerated Approval Submission On The HORIZON For Oncopeptides’ Melflufen

 
• By Bridget Silverman

US FDA says Phase II HORIZON data in relapsed triple-class refractory multiple myeloma can support NDA; Oncopeptides aims for submission Q1 2020.

Multiple myeloma (showing flame-shaped plasma cell) - Image
Recent regulatory discussions on Oncopeptides multiple myeloma candidate were “even better than we anticipated.” • Source: Shutterstock

Oncopeptides AB has started to prepare a new drug application for its multiple myeloma therapy melflufen after the US Food and Drug Administration indicated that the data available from the ongoing Phase II HORIZON trial could support a submission under the accelerated approval pathway.

The NDA will seek approval for treatment of relapsed triple-class refractory multiple myeloma patients, a population who have limited treatment options, the Swedish company said on 20 May. Patients in the HORIZON trial were refractory to at least one agent each from three major classes of multiple myeloma therapy: immunomodulatory drugs (IMiDs), which include Celgene Corp.’s Pomalyst (pomalidomide) and Revlimid (lenalidomide), proteasome inhibitors like Takeda Pharmaceutical Co. Ltd

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