On July 2nd, Johnson & Johnson's South Korean company announced that its bispecific antibody drug, Talquetamab, has been approved for sale in South Korea.
According to the financial news app, on July 2nd, Johnson & Johnson announced that its bispecific antibody drug, Talquetamab, has been approved for sale in South Korea. Its indication is for monotherapy treatment of relapsed or refractory multiple myeloma in adult patients who have received at least three previous treatments, including proteasome inhibitors, immunomodulators, and anti-CD38 antibodies.
It is understood that Talquetamab is an off-the-shelf, subcutaneous injection targeting GPRC5D and CD3 first-in-class bispecific antibody. It was previously approved by the FDA in the United States 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 as a weekly 0.4 mg/kg or biweekly 0.8 mg/kg treatment in patients with three or more previous treatment failures or refractory multiple myeloma. Based on the results of this study, Talquetamab has previously been approved by the FDA.
It is worth mentioning that in China, the application for the marketing authorization of Talquetamab (Tacutamab monotherapy) has been accepted by the Center for Drug Evaluation of the National Medical Products Administration in February 2024 and has been included in the priority review for monotherapy treatment of relapsed or refractory multiple myeloma in adult patients who have received at least three previous treatments.