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Lilly’s Breast Cancer Drug Gets Priority Review Status by FDA

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Eli Lilly and Company LLY announced that its new drug application for its pipeline candidate, abemaciclib, both as a potential monotherapy and combination therapy, has been accepted for priority review by the FDA for patients with advanced breast cancer.

Lilly is looking to get the CDK 4/6 inhibitor approved for two breast cancer indications. Firstly, 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. Secondly, as a combination therapy with fulvestrant in HR+, HER2- advanced breast cancer patients who had disease progression following endocrine therapy.

While the monotherapy submission is based on data from the MONARCH 1 study, the combination application is based on data from the MONARCH 2 study.

Notably, Lilly’s share price has increased 11.8% so far this year, slightly better than the Zacks-classified Large-Cap Pharma industry’s gain of 11.1%.


Coming back to the latest news, with the FDA granting priority review, a decision is expected in the first quarter of 2018. Regulatory applications in the EU and Japan are also anticipated to be filed in the third quarter of this year and before the year end, respectively.

Data from the MONARCH 2 study presented in Mar 2017 showed that the addition of abemaciclib to fulvestrant led to a statistically significant improvement in progression-free survival (PFS) when compared with placebo plus fulvestrant.

Separately, abemaciclib is also being evaluated in a phase III study MONARCH 3 for the first-line treatment of advanced breast cancer. Lilly plans to begin global regulatory submissions of these results in the third quarter of 2017. Meanwhile, abemaciclib is being evaluated in phase III studies for lung cancer as well.

Other available CDK4/6 inhibitors in the market include Pfizer, Inc.’s PFE Ibrance and Novartis AG’s NVS newly approved Kisqali.

If approved, abemaciclib would help Lilly to gain substantial foothold in the growing breast cancer market. This is because, per the American Cancer Society, breast cancer is likely to impact 2,50,000 women in 2017. Moreover, they expect that up to one-third of the early stage breast cancer patients will develop metastatic disease, subsequently.

Currently, Lilly carries a Zacks Rank #3 (Hold). A better-ranked stock worth considering in the same space is AstraZeneca plc AZN, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of AstraZeneca have rallied 23.1% so far this year. Also, its earnings estimates for 2017 moved up 0.5%, while the same for 2018 climbed 3.3% in the last 60 days. Its earnings performance has been pretty impressive as well, with consistent positive surprises. The company’s average earnings beat for the last four quarters is 142.6%.

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