FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLC Pooled analysis finds correlations between early endpoints and OS in ICI trials

FDA booth stood empty at 2025 ASCO annual meeting

Booth 10025 became an unlikely crowd magnet at the exhibit hall at the annual meeting of the American Society of Clinical Oncology that ended earlier this week.

Makary: Level of evidence is an artificial and dogmatic construct

Mehmet Oz, Robert F. Kennedy Jr., Marty Makary, Jayanta Bhattacharya, and Vinayak Prasad at an FDA Roundtable on Cell and Gene Therapy, June 5.Speaking at an FDA Roundtable on Cell and Gene Therapy, FDA Commissioner Marty Makary questioned the construct of “levels of evidence” as artificial and dogmatic, saying that n-of-1 “stories” can drive regulatory decisions.

FDA rolls out agency-wide AI tool

FDA rolled out a generative artificial intelligence tool designed to help employees across the agency “work more efficiently.”

S2302 Pragmatica-Lung reports out as model for faster, leaner, more representative trials

The SWOG S2302 Pragmatica-Lung trial, which broke new ground with its streamlined pragmatic design, unusually broad eligibility criteria, and reduced data collection, has quickly answered its primary question, finding that the investigational combination it tested did not significantly extend overall survival compared to standard of care treatments.

June 06, 2025

Vol.51 No.22

Clinical Roundup

MD Anderson study: Triple therapy regimen significantly improves survival in BRAF V600E-mutated metastatic colorectal cancer

First-line treatment with the triplet combination of encorafenib, cetuximab, and mFOLFOX6 significantly improved survival compared to the standard of care in patients with BRAF V600E-mutated metastatic colorectal cancer, according to new data from the phase III BREAKWATER trial led by researchers from the University of Texas MD Anderson Cancer Center.

June 06, 2025

Vol.51 No.22

Clinical Roundup

Neoadjuvant immunotherapy + chemo regimen significantly improves long-term survival in NSCLC

Adding immunotherapy to chemotherapy before surgery for patients with operable non-small cell lung cancer improved long-term survival overall compared with chemotherapy alone, according to a clinical trial published June 2 in The New England Journal of Medicine and presented at the annual meeting of the American Society of Clinical Oncology.

June 06, 2025

Vol.51 No.22

FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLC

Pooled analysis finds correlations between early endpoints and OS in ICI trials

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FDA booth stood empty at 2025 ASCO annual meeting

Makary: Level of evidence is an artificial and dogmatic construct

FDA rolls out agency-wide AI tool

S2302 Pragmatica-Lung reports out as model for faster, leaner, more representative trials

MD Anderson study: Triple therapy regimen significantly improves survival in BRAF V600E-mutated metastatic colorectal cancer

Neoadjuvant immunotherapy + chemo regimen significantly improves long-term survival in NSCLC

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