FDA approves new efficacy supplement for Eli Lilly's Verzenio

The FDA approved a new efficacy supplement for Verzenio, Eli Lilly's abemaciclib tablet, under application NDA208716. The submission is listed as supplement number 22, with a submission status of "AP" (approved) and a submission status date of 2026-09-18.¹

The supplement falls under the FDA's "Efficacy" submission class, indicating the update relates to clinical effectiveness data rather than manufacturing or labeling-only changes. The review priority was listed as standard.¹

Verzenio is approved in multiple oral tablet strengths. The product line includes 50mg, 100mg, 150mg, and 200mg tablets of abemaciclib, all administered orally.¹

Following the approval, the FDA posted updated application documents. A revised product label was issued dated September 22, 2026, alongside an approval letter dated the same day.¹

The sponsor of record for the application is Eli Lilly and Company. No further details on the specific clinical data supporting this supplement, such as trial results or the exact indication change, are included in the available regulatory record. Readers seeking the clinical rationale behind this label update should consult the newly posted label document referenced in the FDA's Drugs@FDA database for application number 208716, supplement 022.