Shots:

• The BLA submission is based on the (MajesTEC-1) study to evaluate the safety and efficacy of teclistamab in adults with R/R multiple myeloma
• In the MajesTEC-1 study, investigators assessed efficacy outcomes, including ORR, VGPR, and CR using IMWG criteria along with the safety profile of teclistamab. The results were presented at ASH annual meeting
• Teclistamab is an investigational, off-the-shelf, T-cell redirecting, a bispecific antibody targeting BCMA and CD3 & is currently being evaluated in multiple monothx. & combination studies. The therapy also received ODD from the EC & US FDA for MM while PRIME designation from the EMA and BTD from the US FDA

Ref: PR Newswire | Image: Janssen