Shepshelovich D, et al. - Researchers looked into whether drug approval without a supporting randomized controlled trial (RCT) impacts the probability of modifications in cancer drug indications, dosing, and related toxicities after Food and Drug Administration approval. Logistic regression was used for comparison of indications approved with and without supporting RCTs, and Benjamini-Hochberg false discovery rate method was used to adjust for multiplicity. Label modifications were considered to be major if defined as such in the drug label. Cancer drug indications not initially supported by RCT were shown to be related to more postmarketing safety-related label modifications. Physicians should be attentive to unrecognized adverse effects when prescribing drugs approved without a supporting RCT.