AstraZeneca’s Tagrisso Label Expansion Filing Accepted by EMA
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.
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Astrazeneca PLC (AZN): Free Stock Analysis Report
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