AstraZeneca's Faslodex Gets FDA Nod For Use With Verzenio

AstraZeneca, plc (NYSE:AZN) announced that the FDA has granted approval to a new indication for its breast cancer drug, Faslodex.

The label of Faslodex will now be expanded to include combination use with Eli Lilly’s (NYSE:LLY) new CDK4/6 inhibitor Verzenio/abemaciclib to treat women with HR+, HER2- advanced or metastatic breast cancer whose disease has progressed after endocrine therapy.

The FDA approval was based on the MONARCH 2 study data, which showed that Faslodex+Verzeniosignificantly improved progression-free survival (16.4 months) compared to Faslodex+ placebo.

Shares of this London, United Kingdom based pharma giant have gained 22.2% so far this year, comparing favorably with the industry’s growth of 14%.

In August, Faslodex had received FDA approval for a label extension in the first-line monotherapy setting for the treatment of postmenopausal women with HR+ advanced breast cancer. Until this approval, Faslodex was only approved for advanced breast cancer in later lines of treatment.

We believe that the FDA approval for two new indications for Faslodex in three months can improve sales of the drug in the future quarters. The drug has generated sales of $703 million in 2017 so far, up 16% year over year.

Also, please note that this is the second time that Faslodex has been approved for use in combination with a CDK4/6 inhibitor. It is already marketed in combination with Pfizer’s (NYSE:PFE) Ibrance.

AstraZeneca carries a Zacks Rank #3 (Hold). A better-ranked stock in the large-cap pharma sector is Johnson & Johnson (NYSE:JNJ) with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of J&J are up 20.7% so far this year while earnings estimates for 2018 have gone up by 1.2% over the past 30 days.

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