Bevacizumab (DB00112): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Evolving Therapeutic Landscape

Section 1: Introduction to Bevacizumab: A First-in-Class Anti-Angiogenic Agent

1.1 Developmental History and Regulatory Milestones

Bevacizumab, marketed under the brand name Avastin® and its biosimilars, represents a landmark achievement in oncology, being the first anti-angiogenic agent to gain regulatory approval and enter the clinical armamentarium.[1] Its development was founded upon the pivotal discovery that tumor growth is an angiogenesis-dependent process. The scientific rationale posits that by inhibiting the formation of new blood vessels, a tumor's supply of oxygen and nutrients can be restricted, thereby arresting its growth and metastatic potential.[1] This therapeutic strategy targets a fundamental process of tumorigenesis rather than the cancer cells themselves.

The agent achieved its first major regulatory milestone on February 26, 2004, when the U.S. Food and Drug Administration (FDA) granted approval for its use in combination with chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC).[4] This approval heralded a new era of targeted therapy in oncology. Subsequently, bevacizumab received marketing authorisation from the European Medicines Agency (EMA) on January 12, 2005, and from Health Canada on March 24, 2010, solidifying its role as a global standard of care for various malignancies.[6] The drug's development was driven by a wealth of evidence indicating that vascular endothelial growth factor (VEGF), specifically VEGF-A, is a critical mediator of angiogenesis, lymphangiogenesis, and tumor proliferation, making it an exceptionally attractive therapeutic target.[1]

1.2 Biochemical Profile: A Humanized IgG1 Monoclonal Antibody