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

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Eli Lilly and Company (LLY - Free Report) 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 - Free Report) 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 - Free Report) breast cancer drug, Faslodex, received the FDA approval in August for a label extension in the first-line monotherapy setting for advanced breast cancer.

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 - Free Report) 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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