We conducted a cross-sectional study of cancer medicines approved by the FDA for adult solid tumors between January 1, 2006, and December 31, 2025, including both original and supplemental indication approvals. Approvals were extracted from the FDA’s oncology (cancer)/hematological malignancies approval notifications website,⁶ supplemented by the Drugs@FDA website. Nononcology, diagnostic, hematological, pediatric, and biosimilar/generic drugs as well as approvals related to changes in dosages/reformulations were excluded. Approvals for the same drug in the same disease but for multiple indications, such as both first-line and second-line indications or indications for both treatment naive and previously treated populations, were treated as separate approvals.

For each approval, we extracted the following characteristics: date of approval, drug name and type, cancer location treated, regulatory pathway (regular or accelerated approval), primary efficacy end points for approval, and trial design (randomization, phase). Drug types were clinically categorized as chemotherapy, targeted therapy, kinase inhibitors, immunotherapies, antibody-drug conjugates, and others. If an approval was the result of multiple clinical trials or multiple end points from the same trial, it was treated as 1 approval but the data from each trial and each end point were counted separately and credited for overall survival if 1 of those end points was overall survival. Accelerated approvals that were converted into regular approvals were counted as 1 approval. Descriptive statistics were used to examine characteristics related to approval trends.