Johnson & Johnson (J&J; NYSE: JNJ) has announced that its subsidiary Janssen Korea has received approval in South Korea for Talvey (talequetamab), a treatment for multiple myeloma (MM). The drug is indicated for monotherapy in adult patients with relapsed/refractory MM who have received at least three prior therapies, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies.
Talvey is a first-in-class CD3/GPRC5D-targeted bispecific antibody (BsAb). The approval was supported by data from the MonumenTAL-1 study, which evaluated the molecule in two dosages: 0.4 mg/kg weekly and 0.8 mg/kg biweekly. In patients without prior T-cell reintroduction therapy, the weekly 0.4 mg/kg dose demonstrated an overall response rate (ORR) of 74.1%, a strict complete remission (sCR) rate of 24%, complete remission (CR) in 10%, and very good partial remission (VGPR) in 26% of patients. For patients receiving the biweekly 0.8 mg/kg dose, an ORR of 71.7%, sCR of 30%, CR of 9%, and VGPR of 22% were observed.
Talvey received accelerated approval in the U.S. in August 2023 and is awaiting regulatory decisions in Japan and other markets. In China, J&J filed for conditional approval in February this year, which was immediately granted priority review status.- Flcube.com
