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Lilly's Verzenio Gets Priority Review in First-Line Setting

Zacks Equity Research

Eli Lilly and Company LLY announced that the FDA has granted priority review to its new drug application (NDA) for Verzenio (abemaciclib). This drug is looking forward to get approved for the first-line treatment of advanced breast cancer.

Markedly, the NDA was based upon the positive interim results from MONARCH 3 study. The study compared abemaciclib in combination with an aromatase inhibitor versus an aromatase inhibitor alone as initial endocrine-based therapy in patients with HR+, HER2- advanced breast cancer. A decision from the FDA is expected by June 2018.

So far this year, Lilly’s shares have underperformed the industry. While the stock has been up 17.5%, the industry gained 18.9%.

 

Generally, Priority Review designation from the FDA is granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.

Verzenio, a CDK 4/6 inhibitor, is one such drug that was approved by the FDA last week for two breast cancer indications. The drug got approved as a monotherapy for the treatment of hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer, who had prior endocrine therapy and chemotherapy for metastatic disease and as a combination therapy with fulvestrant in HR+, HER2- advanced breast cancer patients, who had disease progression following endocrine therapy. While the monotherapy submission was based on data from the MONARCH 1 study, the combination application was based on data from the MONARCH 2 study.

We remind the investors that Novartis AG’s NVS Kisqali, is already approved by the FDA. The drug is used in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer.

Also, AstraZeneca, plc’s AZN breast cancer drug, Faslodex, received the FDA approval in August for a label extension in the first-line monotherapy setting for advanced breast cancer.

Eli Lilly and Company Price

Eli Lilly and Company Price | Eli Lilly and Company Quote

Zacks Rank & Stock to Consider

Lilly carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector includes ACADIA Pharmaceuticals Inc. ACAD carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the last 60 days, ACADIA’s loss per share estimates narrowed from $2.63 to $2.52 for 2017 and from $1.92 to $1.85 for 2018. The company delivered positive earnings surprises in two of the trailing four quarters, with an average beat of 7.97%. The share price of the company increased 23% year to date.

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Astrazeneca PLC (AZN) : Free Stock Analysis Report
 
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