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# 16% Oncology Phase 2 Patients Get Drugs Later OKd
- URL: https://www.fdaweb.com/16-oncology-phase-2-patients-get-drugs-later-okd/
- Published: 2025-02-26T12:00:00.000Z
- Updated: 2026-09-14T14:54:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158728

One in six oncology patients in Phase 2 clinical trials receive treatments that are eventually approved by FDA, two Canadian researchers write in the [*Journal of the National Cancer Institute*](https://academic.oup.com/jnci/advance-article/doi/10.1093/jnci/djaf013/8029621?login=false&ref=fdaweb.com), adding that this represents a higher therapeutic value than Phase 1 trials.

The researchers say the proportion improved to one in five when considering National Comprehensive Cancer Network off-label recommendations, and decreased to one in 11 when considering FDA approvals deemed to present substantial clinical benefit by a European Society for Clinical Oncology scale.

The analysis hints at the possibility that certain types of trials present better prospects of receiving a therapy that advances in approval, the report says. Thus, Phase 2 trials involving biomarker enrichment or immunotherapy increased the probability of receiving a later-approved therapy to one in four. Trials testing unapproved drugs showed a therapeutic proportion of one in five, the researchers say, compared to one in 11 for trials testing approved drugs for a new indication.

“Our findings reinforce ambiguity in the classification of drug administration in Phase 2 trials,” the authors conclude. “Most patients who enroll in Phase 2 trials have advanced cancers that lack validated treatment options, as observed in this study. Many such patients are likely to regard a 16% probability of receiving a drug that later secures FDA approval for their condition as favorable odds. We think it can be appropriate to present Phase 2 trial participation as offering a small prospect of benefit.”