The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson’s (J&J, NYSE: JNJ) teclistamab has been granted priority review for the treatment of recurrent or refractory multiple myeloma in China. The drug is being considered for conditional approval due to its breakthrough therapy designation (BTD) status, given that it targets patients who have previously received at least three lines of treatment, including a proteasome inhibitor, an immune modulator, and an anti-CD38 monoclonal antibody (mAb).
Teclistamab’s Mechanism of Action and International Recognition
Teclistamab is a bispecific antibody (BsAb) that targets both B cell maturation antigen (BCMA) and CD3. This innovative approach has earned the drug BTD status in the United States and PRIME status in the European Union, highlighting its potential to significantly improve patient outcomes. Clinical studies have demonstrated that at the recommended Phase II dose (RP2D, 1500 µg/kg subcutaneous injection), teclistamab exhibits good tolerance and offers significant, long-lasting efficacy in treating multiple myeloma.-Fineline Info & Tech
