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FDA-Approved Small Molecule Compounds as Drugs for Solid Cancers from Early 2011 to the End of 2021
Aleksandra Sochacka-Ćwikła1, Marcin Mączyński1, Andrzej Regiec1
1Department of Organic Chemistry and Drug Technology, Faculty of Pharmacy, Wroclaw Medical University, 211A Borowska Street, 50-556 Wroclaw, Poland.
Abstract:
Solid cancers are the most common types of cancers diagnosed globally and comprise a large number of deaths each year. The main challenge currently in drug development for tumors raised from solid organs is to find more selective compounds, which exploit specific molecular targets. In this work, the small molecule drugs registered by the Food and Drug Administration (FDA) for solid cancers treatment between 2011 and 2022 were identified and analyzed by investigating a type of therapy they are used for, as well as their structures and mechanisms of action. On average, 4 new small molecule agents were introduced each year, with a few exceptions, for a total of 62 new drug approvals. A total of 50 of all FDA-approved drugs have also been authorized for use in the European Union by the European Medicines Agency (EMA). Our analysis indicates that many more anticancer molecules show a selective mode of action, i.e., 49 targeted agents, 5 hormone therapies and 3 radiopharmaceuticals, compared to less specific cytostatic action, i.e., 5 chemotherapeutic agents. It should be emphasized that new medications are indicated for use mainly for monotherapy and less for a combination or adjuvant therapies. The comprehensive data presented in this review can serve for further design and development of more specific targeted agents in clinical usage for solid tumors.
Insights
The Food and Drug Administration (FDA) approved 62 small molecule drugs for solid cancers between 2011 and 2022, with most offering targeted therapy rather than traditional chemotherapy.
Area of Science:
- Oncology
- Pharmacology
- Drug Development
Background:
- Solid cancers represent a significant global health burden, driving the need for more effective and selective treatments.
- Developing targeted therapies remains a key challenge in improving outcomes for solid tumor patients.
Purpose of the Study:
- To analyze small molecule drugs approved by the FDA for solid cancers between 2011 and 2022.
- To investigate drug types, structures, mechanisms of action, and therapeutic strategies.
Main Methods:
- Systematic identification and analysis of FDA-approved small molecule drugs for solid tumors (2011-2022).
- Categorization based on therapy type (targeted, hormone, radiopharmaceutical, chemotherapeutic) and mechanism of action.
- Assessment of usage patterns (monotherapy vs. combination/adjuvant therapy).
Main Results:
- 62 new small molecule agents were approved, averaging 4 per year.
- The majority (49) were targeted agents, with 5 hormone therapies and 3 radiopharmaceuticals, versus only 5 chemotherapeutic agents.
- Most new drugs are indicated for monotherapy.
Conclusions:
- Recent FDA approvals for solid cancers predominantly feature targeted agents, reflecting a shift towards precision medicine.
- The data supports the continued development of selective targeted agents for solid tumors.
- Understanding these trends can guide future drug design and clinical application.
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