Johnson & Johnson's Bispecific Antibody Talquetamab Approved in South Korea for Relapsed/Refractory Multiple Myeloma

Intelligent Finance APP learned on July 2 that Johnson & Johnson (JNJ.US) announced the approval and market launch of its bispecific antibody drug talquetamab in South Korea. The indication is for monotherapy in adult patients with relapsed or refractory multiple myeloma who have received at least three prior treatments, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies.

It is reported that Talquetamab is an off-the-shelf, subcutaneously injectable, first-in-class bispecific antibody targeting GPRC5D and CD3. It was granted accelerated approval by the U.S. FDA in August 2023.

According to a press release from Johnson & Johnson, the approval of talquetamab in South Korea was based on the MonumenTAL-1 study, which evaluated the efficacy and safety of talquetamab administered once weekly at 0.4 mg/kg or every two weeks at 0.8 mg/kg in patients who had failed or were refractory to three or more prior treatments. Based on the results of this study, talquetamab had previously received FDA approval for marketing.

Notably, in China, the marketing application for talquetamab (Talquetamab) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in February 2024. It has been granted priority review for the indication of monotherapy in adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy.