Janssen Submits Teclistamab for Myleoma Indication

Janssen has submitted its bispecific teclistamab to FDA seeking an indication to treat patients with relapsed or refractory multiple myeloma. (Bispecific agents are able to bind to two antigens at the same time.)

Fierce Biotech reports that Phase 1 studies showed a solid response rate in heavily treated patients. Last year Janssen said the therapy shrank tumors in 70% of patients whose cancer worsened despite trying several other treatments.

In initial Phase 2 results, teclistamab showed a 62% overall response rate at eight months in patients who had received up to three previous types of treatment.

The company describes teclistamab as an off-the-shelf T-cell redirecting bispecific antibody that targets both B-cell maturation antigen and CD3 receptors. It already was awarded a breakthrough therapy designation by FDA. It is in several clinical trials alone and in combination with other therapies.