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AstraZeneca's Tagrisso Label Expansion Filing Accepted by FDA

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AstraZeneca AZN announced that the FDA has accepted and granted priority review to its supplemental New Drug Application (sNDA) for the label expansion of Tagrisso (osimertinib). AstraZeneca’s sNDA seeks to expand Tagrisso’s label to include first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (“NSCLC”) whose tumors have EGFR mutations.

With the FDA granting priority review, a decision is expected within six months. The drug also enjoys Breakthrough Therapy Designation for this indication, which was granted in October 2017.

A similar application for Tagrisso’s label expansion is under review in the EU and Japan.

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

AstraZeneca’s shares have outperformed the industry year to date. The stock has rallied 22% compared with the industry’s gain of 17.3% during the period.

The sNDA was based on data from the phase III FLAURA study, which compared Tagrisso with the standard-of-care EGFR tyrosine kinase inhibitor (“TKI”) therapy in the first-line lung cancer setting.

Data from the study showed that the risk of progression or death was reduced by more than half in the Tagrisso arm compared to the commonly-used EGFR inhibitors. The median progression-free survival (PFS) 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.

Tagrisso registered sales of $651 million in the first nine months of 2017, reflecting growth of 136% from the year-ago period and accounting for 4% of total sales. A potential approval in the first-line setting will further boost the prospects of the drug.

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

Meanwhile, lung cancer is the most common cause of death among all cancer indications, and its variation in mutations in different genes gives opportunities to different therapies to gain market share.

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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