Eli Lilly and Company (NYSE:LLY) announced that its new advanced breast cancer treatment Verzenio (abemaciclib) has gained FDA approval in first-line setting.
With the latest approval, Verzenio is approved in combination with an aromatase inhibitor (AI -either anastrozole or letrozole) as initial endocrine-based therapy in postmenopausal women with HR+, HER2- advanced/metastatic breast cancer who have had no prior systemic treatment for the advanced disease.
Lilly’s shares have declined 5% this year so far while the industry recorded an increase of 0.8%.
The approval was based on positive interim results from MONARCH 3 study. The study compared Verzenio, a CDK 4/6 inhibitor, plus an AI versus an AI plus placebo in the above mentioned patients. Data from the study showed that Verzenio plus an AI substantially reduced tumor size and delayed disease progression in such patients
Verzenio is already marketed for two breast cancer indications - as a monotherapy for the treatment of HR+, HER2- advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease; and as a combination therapy with AstraZeneca's (NYSE:AZN) Faslodex (fulvestrant)in HR+, HER2- advanced breast cancer patients who had disease progression following endocrine therapy.
Verzenio was launched in the United States in the fourth quarter of 2017 and generated sales of $21 million in the first quarter of its launch. We believe that Verzenio’s label expansion in the previously untreated breast cancer population would drive sales higher in future quarters. Verzenio is under review in the EU.
Other available CDK4/6 inhibitors in the market include Pfizer, Inc.’s (NYSE:PFE) Ibrance and Novartis (NYSE:NVS) Kisqali.
Lilly carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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