Small-molecule inhibitors, immune checkpoint inhibitors, and more: FDA-approved novel therapeutic drugs for solid tumors from 1991 to 2021

• Published in: Journal of hematology and oncology Vol. 15; no. 1; pp. 143 - 63
• Main Authors: Wu, Qing, Qian, Wei, Sun, Xiaoli, Jiang, Shaojie
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 08.10.2022; BioMed Central; BMC
• Subjects: Antibodies, Monoclonal - pharmacology; Antibodies, Monoclonal - therapeutic use; Antimitotic agents; Antineoplastic agents; Antineoplastic Agents - pharmacology; Antineoplastic Agents - therapeutic use; Binding sites; Biological Products - therapeutic use; Biopharmaceuticals; Breast cancer; Cancer; Cancer therapies; Clinical trials; Development and progression; Drug approval; Drug development; Drug resistance; Drug therapy; Epidermal growth factor; FDA approval; Gene therapy; Health aspects; Hematology; Humans; Immune checkpoint; Immune checkpoint blockades; Immune Checkpoint Inhibitors; Immunoconjugates - therapeutic use; Immunosuppressive agents; Immunotherapy; Kinases; Lung cancer; Metastasis; Monoclonal antibodies; Mutation; Neoplasms - drug therapy; Oncology; Pharmaceutical Preparations; Proteins; Receptor tyrosine kinase inhibitors; Respiratory agents; Review; Solid tumors; The United States Food and Drug Administration; Tumors; Tyrosine; United States; United States Food and Drug Administration; Vaccines; United States; Immune checkpoint blockades; Receptor tyrosine kinase inhibitors; Solid tumors; The United States Food and Drug Administration
• ISSN: 1756-8722; 1756-8722
• DOI: 10.1186/s13045-022-01362-9

The United States Food and Drug Administration (US FDA) has always been a forerunner in drug evaluation and supervision. Over the past 31 years, 1050 drugs (excluding vaccines, cell-based therapies, and gene therapy products) have been approved as new molecular entities (NMEs) or biologics license applications (BLAs). A total of 228 of these 1050 drugs were identified as cancer therapeutics or cancer-related drugs, and 120 of them were classified as therapeutic drugs for solid tumors according to their initial indications. These drugs have evolved from small molecules with broad-spectrum antitumor properties in the early stage to monoclonal antibodies (mAbs) and antibody‒drug conjugates (ADCs) with a more precise targeting effect during the most recent decade. These drugs have extended indications for other malignancies, constituting a cancer treatment system for monotherapy or combined therapy. However, the available targets are still mainly limited to receptor tyrosine kinases (RTKs), restricting the development of antitumor drugs. In this review, these 120 drugs are summarized and classified according to the initial indications, characteristics, or functions. Additionally, RTK-targeted therapies and immune checkpoint-based immunotherapies are also discussed. Our analysis of existing challenges and potential opportunities in drug development may advance solid tumor treatment in the future.