Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody TECVAYLI ® (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM)

BEERSE, Belgium, 22 July 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation (CMA) for TECVAYLI® (teclistamab) as monotherapy for adult patients with relapsed and refractory multiple myeloma (RRMM), who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Teclistamab is an off-the-shelf, T-cell redirecting bispecific antibody. It targets both B-cell maturation antigen (BCMA), a marker found on multiple myeloma cells, and CD3, on T-cells.[1]CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.[1] While newer treatment options have nearly doubled survival outcomes for patients living with multiple myeloma over the past few decades, it remains an incurable disease.[2] Nearly all patients will relapse and require subsequent therapy.[3] Generally, efficacy outcomes decrease with each line of therapy, and patients face poor prognoses.[4] In December 2021, the EMA granted accelerated assessment for teclistamab. Accel...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Latest News Source Type: news