GSK Blood Cancer Drug Returns to the U.S. Market, But New FDA Approval Is Still Limited

GSK finally has the long-awaited FDA approval it sought for blood cancer drug Blenrep. Three years after the pharmaceutical giant pulled the multiple myeloma therapy from the market, the FDA approved the drug again. But the new Blenrep regulatory nod announced Thursday comes in a more limited way than GSK wanted and the drug is rejoining a market that has grown and changed since it left.

Multiple myeloma is a blood cancer that develops in plasma cells, a type of white blood cell. Blenrep is an antibody drug conjugate (ADC) designed to target BCMA, a protein abundant on the surface of these cancerous cells. The FDA awarded Blenrep accelerated approval in 2020 as a fifth-line monotherapy for multiple myeloma. Two years later, Blenrep failed its confirmatory Phase 3 test. GSK withdrew th