The Landscape of FDA Approvals – NEW BG Lab Paper in JAMA

July 30, 2026. BG Lab is  very excited  to announce that our newest paper has been published in  JAMA, “Cancer Medicine Approvals in the US”.

In this paper, we study all cancer drugs approved by the FDA in the last 20 years: 2006-2025. In this analysis of  385 FDA approvals of cancer drugs, we find several interesting  trends worthy of highlighting.

Key Findings:  

1. Across the full 20-year period, 102 approvals (26.5%) were based on  overall survival  and 283 (73.5%) were based on  surrogate endpoints.  

2. The proportion of approvals based on  overall survival has decreased  from 40% in 2006-2010 to 18.7%  from 2021-2025.  

3. Progression-free survival  was the most common surrogate endpoint (60%) from 2006-2015. From 2016-2025,  objective response rate became the most common (46.7%).  This is a key finding:  the commonest surrogate endpoint now is not PFS but ORR.  

4. There is an  increase in the  utilization  of regular approval pathways  for surrogate  endpoint-based  approvals.  The proportion  of regular approvals&n bsp;based on surrogate endpoints increased from 53.8% in 2006-2010 to 74.8% in 2021-2025.  

5. The share of approvals supported by  single-arm trials  rose from 12.9% in 2006–2010 to 37.2% in 2021-2025.  

6. Chemotherapy used to be commonest type of drug approved in 2006-2010, but it  constituted  less than 4% of approvals in 2021-2025.

7. Lung and breast cancer subtype accounted for the largest share of drug approvals.  

This publication is important to BG Lab for many reasons. First, this is the first first-author publication for Brian Shkabari.  Second, all authors of this paper (aside from BG) are undergraduates  and have been taught by Dr. Gyawali in the Bachelor of Health Sciences GLPH 488 course at Queen’s.  Third, this is the first publication in the main JAMA journal (i.e. excluding other JAMA family journals) for BG Lab and all  the authors.  

Overall, this paper illustrates the philosophy of our lab where we not only  work to challenge the status quo in oncology, but also have projects led and developed by the next generation of thinkers in our field.

We are super proud of this paper led, run, and executed by an entirely undergraduate team of students and researchers.  

Authors:  Brian Shkabari,  BHSc;  Nicole I.  Vorko,  BHSc; Wesley M.  Geerlinks,  BHSc; Elizaveta  Purh,  BHSc;  Claire M. Diana-Gonsalves,  BHSc;  Svasti  Sutaria, BSc; and Bishal Gyawali, MD, PhD.  

Media contact:   

Bishal Gyawali: gyawali.bishal@queensu.ca  

X: @oncology_bg,  oncologybglab