A Comprehensive Clinical and Pharmacological Review of Teclistamab (Tecvayli): A First-in-Class BCMAxCD3 Bispecific Antibody for Relapsed/Refractory Multiple Myeloma

Section 1: Introduction and Drug Profile

1.1. Overview

Teclistamab, marketed under the brand name Tecvayli, represents a significant milestone in the treatment of multiple myeloma, a hematologic malignancy characterized by the proliferation of cancerous plasma cells.[1] It is a first-in-class, off-the-shelf bispecific T-cell engager (BiTE) antibody developed by Janssen Pharmaceuticals.[2] The therapy is specifically designed to address the profound unmet medical need for patients with relapsed and refractory multiple myeloma (RRMM) who have exhausted multiple prior lines of standard therapy, including proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies.[1]

The development and approval of Teclistamab herald a new era of immunotherapy for this incurable disease. Its novel mechanism of action, which leverages the patient's own immune system to target and eliminate malignant cells, has demonstrated impressive rates of deep and durable responses in a heavily pretreated population with a historically poor prognosis.[1] In recognition of its potential to substantially improve upon available therapies, Teclistamab received accelerated and conditional marketing authorizations from major global regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).[2] This report provides an exhaustive clinical and pharmacological review of Teclistamab, detailing its mechanism, the pivotal clinical evidence supporting its use, its comprehensive safety profile, and its strategic position within the evolving therapeutic landscape of multiple myeloma.

1.2. Identification and Physicochemical Properties