Janssen Korea received approval to initiate a Phase III trial for its first-in-class investigational bispecific antibody ‘talquetamab’ for multiple myeloma in Korea.

The drug is ‘Talvey,’ which was approved by the US FDA in August. The FDA granted accelerated approval to Talvey based on its overall response rate and duration of response. Its continued approval will depend on the results of the Phase III confirmatory trial.

The phase 3 drug trial approved in Korea this time is for the indication approved by the FDA.

The FDA approved Talvay for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, inc