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Eli Lilly's Breast Cancer Drug Gets Breakthrough Status

Eli Lilly and CompanyLLY announced that the FDA has granted Breakthrough Therapy designation to its CDK 4/6 inhibitor, abemaciclib, for the treatment of patients suffering from refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.

We note that Breakthrough Therapy designation is granted by the FDA to expedite the development and review of a candidate that is believed to have the potential to treat a serious condition and preliminary clinical evidence may show substantial improvement over existing therapies on a clinically significant endpoint.

Currently, Eli Lilly is conducting phase II (MONARCH 1 - monotherapy in women with HR+, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer) and phase III studies (MONARCH 2 and MONARCH 3) on abemaciclib for the treatment of breast cancer.

While MONARCH 2 is studying abemaciclib in combination with AstraZeneca plc's AZN Faslodex (fulvestrant) in postmenopausal patients with HR+, HER2- advanced or metastatic breast cancer, MONARCH 3 is evaluating abemaciclib plus a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer.

We are encouraged by the FDA granting Breakthrough Therapy designation to abemaciclib, which will expedite its development process. According to the World Cancer Research Fund International and American Cancer Society, breast cancer is the most common cancer in women across the world and almost 232,000 women are expected to be diagnosed with invasive breast cancer resulting in about 40,000 deaths in the U.S. each year.

We note that Pfizer Inc.'s PFE breast cancer drug, Ibrance (palbociclib), gained accelerated approval from the FDA earlier this year. Ibrance was the first CDK 4/6 inhibitor to be approved by the FDA.

Both Eli Lilly and AstraZeneca are Zacks Rank #1 (Strong Buy) stocks. Another equally well-ranked stock in the health care sector is Apricus Biosciences, Inc. APRI .

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ASTRAZENECA PLC (AZN): Free Stock Analysis Report

PFIZER INC (PFE): Free Stock Analysis Report

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APPRICUS BIOSCI (APRI): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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