FDA Nods To AstraZeneca's Tagrisso For First-Line NSCLC

AstraZeneca (NYSE:AZN) announced that it has secured an FDA approval for the label expansion of its marketed drug, Tagrisso (osimertinib), for first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.

Notably, Tagrisso is approved in the United States, European Union, Japan and China as second-line treatment for patients with advanced NSCLC, who showed progress following treatment with an EGFR TKI due to the EGFR T790M resistance mutation.

Shares of AstraZeneca have outperformed the industry year to date. The stock has gained 3.7% versus the industry’s decline of 3.3%.

We remind investors that last December, the FDA accepted and granted a priority review to the company’s supplemental New Drug Application (sNDA) for Tagrisso for the aforementioned indication.

The FDA nod was based on positive data from the phase III FLAURA study, which compared Tagrisso with the standard-of-care EGFR tyrosine kinase inhibitor therapy in the first-line lung cancer setting.

Data from the trial showed that the chance of progression or death risk was reduced by more than half in the Tagrisso arm compared with the commonly-used EGFR inhibitors. The median progression-free survival was 18.9 months for patients on Tagrisso compared with 10.2 months in the comparator arm. Tagrisso was well-tolerated in the trial with a safety profile, consistent with the previous experience.

Importantly, a similar application for Tagrisso’s label expansion is under review in the EU as well as Japan with a decision expected in the second half of 2018.

Tagrisso registered sales of $955 million in 2017, reflecting growth of 126% from the year-ago period and accounting for 5% of total sales. A potential approval in the first-line setting will further boost the drug’s prospects.

However, the lung cancer market is crowded with several companies developing or marketing treatments. While Roche Holding (SIX:ROG) AG (OTC:RHHBY) /Astellas’ Tarceva is approved for treating NSCLC, Pfizer Inc. (NYSE:PFE) is developing its drug Xalkori in a phase III study as a first-line treatment for the indication. Moreover, Bristol-Myers Squibb (NYSE:BMY) is developing Opdivo as a treatment for NSCLC and AstraZeneca too has Iressa approved for treating NSCLC and is also developing Imfinzi for the same indication.

Zacks Rank

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

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