Zhitong Finance and Economics learned that a few days ago, Johnson & Johnson (jnjUS) announced that the U.S. FDA has approved a Supplemental Biologics License Application (SBLA) for Tecvayli (Teclistamab), a bispecific antibody targeting B-cell maturation antigen (BCMA), for reducing the dosing frequency to bi-weekly dosing in patients with ** or refractory multiple myeloma (RRMM) (15 mg kg), these patients have achieved and maintained a complete response (CR) for at least six months. This approval provides greater flexibility in dosing regimens for patients on weight-based** regimens.
It is reported that the approval is mainly based on the results of the Phase 2 trial of Majestec-1 clinical trial. In this study, patients initially received the recommended Phase 2 dose (RP2D, 1.) once a week5 mg kg) subcutaneous injection of tecvayli**. When a patient has achieved a confirmed CR for more than six months, they are eligible to reduce the frequency of dosing to bi-weekly (1.)5 mg kg) until disease progression or unacceptable toxicity.
Previously published positive outcome data from the Majestec-1 trial showed an overall response rate of 63% in 165 RRMM patients who received weekly subcutaneous TECLIMABs, and it is worth mentioning that 588% of patients achieved a very good partial response (VGPR) or above,39Four percent of patients achieved a response of complete response (CR) or greater.