J&J Hits Another Myeloma Milestone With FDA Approval Of Talvey

Johnson & Johnson’s Janssen Pharmaceutical Cos. has further strengthened its market position in the treatment of multiple myeloma with the US Food and Drug Administration accelerated approval of Talvey (talquetamab-tgvs) as the first approved GPRC5DxCD3-targeting bispecific antibody to treat the disease. In addition to being the third first-in-class myeloma drug from Janssen to win approval, Talvey also means the drug maker has options for treatment from the time of diagnosis all the way through later lines of therapy.

The FDA granted Talvey accelerated approval on 9 August, based on results from the Phase II MonumenTAL-1 trial among patients who had at least four prior lines of therapy – including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody – and received subcutaneous Talvey at 0.4mg/kg weekly or 0.8mg/kg biweekly