FDA accelerated approval of Johnson&Johnson's bispecific antibody Tecvayli
On October 25, the US FDA accelerated the approval of Johnson&Johnson's bispecific antibody Tecvayli (Teclistamab) for the four line treatment of recurrent or refractory multiple myeloma. Teclistamab is an antibody that can be injected subcutaneously. The maintenance treatment only needs to be injected once a week, which is an advantage over intravenous products.
The clinical trial showed that 68 of the 110 patients participating in the trial had a response, and the objective response rate was 61.8%, of which 31 patients had complete remission, with a complete remission rate of 28.2%. Due to accelerated approval, the clinical trial end point of this product is not yet mature. According to literature reports, there are about 10000 second-line patients with multiple myeloma in the world, but there are many approved drugs at present. In addition to the advantages of curative effect, the key of this pint is the development of first-line, second-line and three-line therapies. In addition, before FDA, EMA approved the product in August.