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AstraZeneca's Faslodex Gets FDA Nod in First-Line Setting

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AstraZeneca, plc AZN announced that Faslodex has received FDA approval for a label extension in the first-line monotherapy setting for the treatment of advanced breast cancer.

Faslodex has  been approved as a monotherapy treatment for previously untreated post-menopausal women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

So far this year, AstraZeneca’s shares have moved up 7%, comparing unfavorably to a 10.8% increase for the industry.

Coming back to the latest news, the FDA approval was based on data from the phase III FALCON study. The FALCON study evaluated the anti-tumor effects and tolerability profile of Faslodex (500 mg) plus placebo in comparison to anastrozole (1 mg) plus placebo.

Data from the study showed that treatment with Faslodex led to 20% reduction in disease progression or death versus anastrozole, the current standard of care treatment.

We note that Faslodex is currently approved in the United States 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 United States in combination with Pfizer Inc.’s 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.

We remind investors that Faslodex was approved in the same first-line indication in the EU in July and in Japan in June.

The latest approval in the first-line setting is expected to improve the sales of the drug.

In the first half of 2017, Faslodex generated sales of $462 million, up 15% year over year.

AstraZeneca currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Stocks to Consider

Some better-ranked pharma/biotech stocks are Gilead Sciences, Inc. GILD and Regeneron Pharmaceuticals, Inc. REGN. While Regeneron sports a Zacks Rank #1, Gilead carries a Zacks Rank #2 (Buy).

Regeneron’s shares have moved up 30.1% this year so far. Estimates have risen 15.1% for 2017 while that for 2018 have gone up by 5.8% over the last 30 days.

Shares of Gilead have rallied 3% so far this year while estimates for 2017 and 2018 have inched up almost 07% and 0.1%, respectively, over the last 30 days.

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Astrazeneca PLC (AZN) : Free Stock Analysis Report
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