AstraZeneca Plc. AZN announced that the European Medicines Agency (EMA) has accepted a variation to the Marketing Authorisation Application (MAAv) for the label expansion of Tagrisso (osimertinib). AstraZeneca is looking to get Tagrisso approved for the first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.

Tagrisso is already approved in the United States, European Union, Japan and China as a second-line treatment option for patients with EGFR mutation-positive NSCLC.

The label expansion regulatory application was based on data from the phase III FLAURA study, evaluating Tagrisso compared with the standard-of-care EGFR tyrosine kinase inhibitor (TKI) therapy in the first-line lung cancer setting.

The data showed that treatment with Tagrisso reduced the risk of progression or death by more than half compared with the commonly-used EGFR inhibitors for the first-line treatment of patients with EGFR mutation-positive NSCLC. The median progression-free survival (PFS) was 18.9 months for patients on Tagrisso as compared to 10.2 months in the comparator arm. Tagrisso was well-tolerated in the trial with a safety profile, consistent with the previous experience.

So far this year, AstraZeneca’s shares have outperformed the industry. The stock has been up 22.7% compared with the industry’s gain of 16.2%.

In October, Tagrisso was granted a breakthrough therapy designation by the FDA for the aforementioned indication.

Earlier this week, AstraZeneca also filed a regulatory application in Japan to expand the label of Tagrisso in the first line setting.

Zacks Rank & Stocks to Consider

AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space are Sucampo Pharmaceuticals SCMP,Ligand Pharmaceuticals LGND and Corcept Therapeutics Incorporated CORT. While Sucampo sports a Zacks Rank #1 (Strong Buy), Ligand and Corcept hold a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings per share estimates have moved up from $1.01 to $1.12 for 2017 and from $1.06 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%.

Ligand’s earnings per share estimates have climbed $3.68 to $3.70 for 2018 over the last 60 days. The company pulled off a positive earnings surprise in two of the trailing four quarters, with an average beat of 8.22%. The share price of the company has increased 28.5% year to date.

Corcept’searnings per share estimates have moved up from 78 cents to 88 cents for 2018 over the last 30 days. The company delivered positive earnings surprises in two of the trailing four quarters, with an average beat of 14.32%. The share price of the company has increased 149.8% year to date.

Investor Alert: Breakthroughs Pending

A medical advance is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating substantial revenue, and even more wondrous products are in the pipeline.

Cures for a variety of deadly diseases are in sight, and so are big potential profits for early investors. Zacks names 5 stocks to buy now.

Click here to see them >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Astrazeneca PLC (AZN): Free Stock Analysis Report
 
Ligand Pharmaceuticals Incorporated (LGND): Free Stock Analysis Report
 
Sucampo Pharmaceuticals, Inc. (SCMP): Free Stock Analysis Report
 
Corcept Therapeutics Incorporated (CORT): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research