FDA grants accelerated approval to Bristol Myers' Zenbexus, first CELMoD for multiple myeloma

The FDA issued an accelerated approval on Thursday for Zenbexus, a multiple myeloma therapy that Bristol Myers Squibb inherited from its Celgene acquisition.

Zenbexus belongs to a new class of protein-degrading agents known as CELMoDs, which use the cell's waste-disposal pathways to eliminate malignant cells. Analysts note this is the first FDA clearance for any CELMoD and could revitalize the company's myeloma franchise, which has faced pressure from generic competition.

The approval allows Zenbexus to be used in second-line treatment together with Johnson & Johnson's Darzalex and dexamethasone. Some market observers suggest the combination may begin to replace existing Darzalex-based regimens, including those that pair Darzalex with Bristol Myers' Revlimid or Pomalyst, or Amgen's Kyprolis.