Remission rate reaches 62% Janssen submits bispecific antibody marketing application

Today, Johnson & Johnson's Janssen Company (Janssen) announced that it has submitted a biologics license application (BLA) for teclistamab to the US FDA for the treatment of relapsed or refractory (R/R) multiple myeloma (MM) Patient

MM is a malignant disease caused by the abnormal proliferation of clonal plasma cells.

BCMA is a popular target for the treatment of B-cell blood cancers and is highly expressed in multiple myeloma cells

The submission of this BLA is supported by the positive results of a multi-center Phase 1/2 clinical trial evaluating the efficacy and safety of teclistamab

Reference materials:

[1] Janssen Submits Biologics License Application to US FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma.

[2] New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma.