Eli Lilly's Verzenio snags first-in-class FDA approval for early breast cancer. But limited label poses a challenge

As a late entrant in the breast cancer race, Eli Lilly has leapt ahead of rivals Pfizer and Novartis with a first-in-class FDA approval. But a patient population restriction is adding what Lilly Oncology chief called “a legitimate challenge” to the launch.

The FDA has greenlighted Lilly’s Verzenio, used in tandem with endocrine therapy, to treat certain patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence after surgery, Lilly said Wednesday. There’s a catch: Only patients who test at least 20% on the cellular proliferation marker Ki-67 are eligible for the new regimen.