FDA backs earlier use of Lilly’s breast cancer drug Verzenio

Eli Lilly has picked up yet another FDA approval for CDK4/6 inhibitor Verzenio - its third in five months - as it tries to chase down Pfizer’s category-leading Ibrance.

The US regulator has given the nod to Verzenio (abemaciclib) for use in combination with an aromatase inhibitor as initial endocrine-based therapy for women with breast cancer who are hormone receptor-positive (HR+) and HER2 receptor-negative (HER2-).

The approval is based on the results of the MONARCH 3 trial, which showed adding Verzenio to aromatase inhibitors letrozole or anastrozole improved progression-free survival (PFS) in women with HR+/HER2-negative breast cancer. In the trial Verzenio given twice daily alongside an aromatase inhibitor achieved a greater than 28-month median progression-free survival (PFS), compared to 14.8 months with endocrine therapy alone.

Verzenio was approved in the US last year to treat HR+/HER2- breast cancer in patients whose disease had progressed after endocrine therapy with letrozole and anastrozole, either alone or in combination with fulvestrant, based on the MONARCH 1 and MONARCH 2 data. The new indication means it can be used further up the treatment pathway, and Lilly is also running a phase III trial called monarchE that will test Verzenio as adjuvant therapy in early breast cancer.

The pharma company reckons Verzenio has the potential to be a best-in-class drug that can mount a strong challenge to Ibrance (palbociclib - which grew 46% to $3.1bn last year and is predicted to become a $6bn product at peak by EvaluatePharma - as well as Novartis’ second-to-market CDK4/6 inhibitor Kisqali (ribociclib)).

Kisqali made $35m in its first few months on the market after launches in the US and Europe in the second half of 2017, not quite as much as Novartis hoped. Lilly’s product meanwhile is off to a promising start, making $21m in the last quarter of the year after a US launch in mid-October, thanks in part to its continuous dosing regimen which avoids patients having to take treatment holidays to avoid toxicity such as neutropenia, as well as the flexibility of its monotherapy indication.

“This approval is an important milestone, as it shows that Verzenio plus an aromatase inhibitor substantially reduced tumour size and delayed disease progression in women with hormone receptor-positive, HER-2-negative metastatic breast cancer,” said Joyce O'Shaughnessy, chair of the breast cancer research programme for Baylor University Medical Center, in a press release.

“This information will help inform treatment decisions for each patient, which can be complicated in advanced breast cancer.”