Johnson & Johnson Receives CDE Approval for New Clinical Trial of Talquetamab in Combination with Daratumumab and Lenalidomide for Newly Diagnosed Multiple Myeloma

Intelligent Finance APP learned on October 12 that, according to the CDE official website, Johnson & Johnson (JNJ.US)’s new clinical trial application for Talquetamab has received tacit approval. It will be used in combination with Daratumumab (subcutaneous injection) and Lenalidomide (Tal-DR) to treat adult patients with newly diagnosed multiple myeloma who are not suitable for or do not plan to undergo autologous stem cell transplantation as initial treatment.

Talquetamab is a CD3/GPRC5D bispecific antibody developed by Johnson & Johnson. It received accelerated FDA approval in August this year for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have previously received at least four prior lines of therapy (including proteasome inhibitors, immunomodulatory agents, and CD38 antibodies). The approval was based on the results of the Phase I/II MonumenTAL-1 clinical trial.