AstraZeneca Reports Positive Phase III Data On Faslodex

AstraZeneca plc (NYSE:AZN) announced positive data from a phase III study (FALCON) on its breast cancer drug, Faslodex (fulvestrant/500mg), for the treatment of locally-advanced or metastatic breast cancer in post-menopausal women who have not received prior hormonal treatment for hormone-receptor-positive (HR+) breast cancer.

The FALCON study evaluated the anti-tumor effects and tolerability profile of Faslodex plus placebo, in comparison to Arimidex (anastrozole/1mg) plus placebo.

Data from the study demonstrated superiority of Faslodex (500mg) over Arimidex (1mg), thereby meeting the primary endpoint of extended progression-free survival. The study, however, showed an adverse event profile, which is consistent with the current safety profile of the drugs.

Currently, the company is evaluating results from the study and expects to present the same at a medical meeting later this year.

We note that Faslodex is currently approved in the U.S. for the treatment of postmenopausal women with estrogen-receptor (ER)-positive locally-advanced or metastatic breast cancer whose cancer has progressed following anti-estrogen therapy. The drug is also approved in the U.S. in combination with Pfizer Inc.’s (NYSE:PFE) Ibrance (palbociclib), for the treatment of HR+, human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer in women whose cancer has progressed after endocrine therapy.

In the first quarter of 2016, Faslodex generated sales of $190 million, up 18% year over year.

Meanwhile, in a separate press release, the company announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on its Onglyza-Farxiga tablets.

The Committee has recommended the approval of a fixed-dose combination of Onglyza (saxagliptin) and Farxiga (dapagliflozin) for the treatment of adults with type II diabetes. The combination was recommended to be approved as a treatment to improve glycemic control in cases where metformin and/or sulphonylurea, and one of the mono-components of Onglyza-Farxiga alone, do not provide adequate glycemic control, or when a patient is already being treated with the free combination of Onglyza and Farxiga.

A final decision on the approval is expected in the coming months.

Currently, AstraZeneca carries a Zacks Rank #3 (Hold). Bristol-Myers Squibb Company (NYSE:BMY) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) are a couple of better-ranked stocks in the health care sector. Both stocks sport a Zacks Rank #1 (Strong Buy).

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