AstraZeneca PLC (AZN - Free Report) announced that it has secured an approval from China for the label expansion of its marketed drug Tagrisso (osimertinib) for the first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.
The nod by China’s National Medical Products Administration was based on positive data from the phase III FLAURA study.
In the study, treatment with Tagrisso showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression in the first-line setting. The median PFS was 18.9 months for patients on Tagrisso compared with 10.2 months in the comparator arm.
So far, Tagrisso was approved in China as a second-line treatment option for patients with EGFR mutation-positive NSCLC.
In August 2019, AstraZeneca announced overall survival (OS) data from the FLAURA study, which showed that Tagrisso substantially improved OS in the above-mentioned patient population. Tagrisso was approved for the above indication based on PFS data from the same study in the United States and the EU in 2018. OS was the secondary endpoint in the study and AstraZeneca expects to present this data at an upcoming medical meeting.
Shares of AstraZeneca have rallied 19.3% so far this year against the industry’s decline of 0.7%.
Since its approval, Tagrisso has been a steady performer and a key contributor to AstraZeneca’s top line.
During the first half of 2019, Tagrisso generated sales of $1.4 billion, driven by consistent underlying demand growth and a rapid uptake in the first-line setting. The label expansion nod for this important cancer drug should drive sales higher in the future quarters.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large-cap pharma sector include Merck & Co., Inc. (MRK - Free Report) , Novartis AG (NVS - Free Report) and Eli Lilly and Company (LLY - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings estimates have moved 3.2% north for 2019 and 1.3% for 2020 over the past 60 days. The stock has gained 12.6% year to date.
Novartis’ earnings estimates have been revised 2.8% upward for 2019 and 3.4% for 2020 over the past 60 days. The stock has inched up 4% year to date.
Eli Lilly’s earnings estimates have been inched 1.1% up for 2019 and 0.6% for 2020 over the past 60 days.
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