Janssen's Teclistamab Receives Third Breakthrough Therapy Designation from CDE for Relapsed/Refractory Multiple Myeloma

On March 24, the CDE website showed that Johnson & Johnson's Teclistamab (Tecvayli) injection may be included in the breakthrough therapy category.For relapsed or refractory multiple myeloma patients who have previously received at least one prior line of therapy.（R/R MM）Adult Patients。

Source: CDE Official Website

This isTalimogene Laherparepvec Granted Breakthrough Therapy Designation by CDE for the Third Time, The other two indications are respectively: for the treatment ofHaving received at least 3 prior lines of therapyR/R MMAdult Patients, whose previous treatments included a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody;In combination with daratumumab, it is applicable to patients who have received at least one prior line of therapy.R/R MMAdult Patients。

Talimogene laherparepvec is aWorld's first, ready-to-use, weight-based subcutaneous injectionBCMA × CD3 Bispecific Antibody, which was successively approved for marketing by the EMA in August 2022 and the FDA in October 2022. As a single agent, it is suitable for adult patients with R/R MM who have received at least three prior lines of therapy. In June 2024, this product was approved in China for the same indication.

Since its launch, Teclistamab sales reached $670 million in 2025, and it is on track to join the billion-dollar molecule club.

Currently, the globally approved BCMA × CD3 bispecific antibodies also includeElranatamab (Pfizer), Linvoseltamab (Regeneron); The pipeline under research includes ABBV-383 (TNB-383B, AbbVie). In addition, the bispecific antibody approved for the treatment of multiple myeloma also...Including Talquetamab (Johnson & Johnson) and Cevostamab (Roche)etc.

Reference: DXY Insight Database

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