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Evolution of Precision Oncology: Trends and Considerations from FDA Approvals (1998-2022)

NextEdge Admin

23 Apr 2024

3 min 11 sec

Revisiting the previous study published in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) revealed that nearly half of the anti-cancer drugs approved by the FDA from 1998 to 2022 were precision therapies, marking a significant advancement in the field of oncology. Led by Debyani Chakravarty, PhD, the study underscores the exponential growth of precision oncology since the approval of trastuzumab (Herceptin) in 1998. This growth is attributed to decreasing costs of genomic sequencing and technological advancements.

Out of the 198 anticancer therapeutics approved during this period, approximately 43 percent were classified as precision oncology drugs. These include kinase inhibitors, monoclonal antibodies, small molecule inhibitors, and immune checkpoint inhibitors, all requiring genomic biomarker screening for patient selection. The analysis revealed a gradual increase in FDA approvals of precision oncology therapies until 2017, followed by a rapid surge until 2022.

However, the study also highlights certain limitations and challenges. Despite the growth, most therapies targeted a limited number of biomarkers, indicating a narrow scope of drug development. Additionally, while the percentage of patient samples eligible for precision therapies doubled from 2017 to 2022, there remains a significant portion with non-actionable alterations. The clinical impact of precision oncology is debated, with concerns over accessibility due to high costs and insurance coverage limitations.

The study emphasizes the need for innovative approaches to address multiple genomic alterations and expand the scope of actionable genetic targets. Universal genetic testing is advocated to develop treatments for rare genomic alterations, regardless of tumor origin. However, the analysis lacks data on whether eligible patients received precision therapies, highlighting gaps in healthcare delivery and disparities in access.

While precision oncology has become integral to cancer care, challenges remain in widening the scope of actionable targets, improving accessibility, and ensuring equitable distribution of treatments. Continued research and innovation are essential to maximize the clinical impact of precision therapies and improve outcomes for cancer patients worldwide.