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Japan Nods to AstraZeneca's Tagrisso for First-Line NSCLC
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AstraZeneca (AZN - Free Report) announced that it has secured a Japanese approval for the label expansion of its marketed drug, Tagrisso (osimertinib) for first-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
A similar label expansion application was approved in the United States in April and in EU in June. Until now, Tagrisso was approved in the United States, European Union, Japan and China as a second-line treatment option for patients with EGFR mutation-positive NSCLC.
The first-line approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) 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 study 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.
Shares of AstraZeneca outperformed the industry year to date. The stock gained 11.9% compared with the industry’s gain of 5.6%.
During the second quarter of 2018, Tagrisso recorded sales of $422 million, up 77% year over year, driven by increased testing rates. On the call, the company said it saw an encouraging start to the first line launch in the United States., which contributed to sales growth.
The company said that Tagrisso achieved market leadership in new patient starts in the United States in the first-line setting. In Europe, Tagrisso was launched for the first-line indication in select EU countries, including in France and Germany. The approvals in Japan and EU should drive sales of Tagrisso higher in future quarters.
We note that Merck’s (MRK - Free Report) Keytruda is the only anti-PD-1 approved in the first-line lung cancer setting both as a monotherapy as well as combination therapy.
Gilead’s earnings per share estimates have increased from $6.15 to $6.57 for 2018 and from $6.33 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 1.0% so far this year.
Celgene’s earnings per share estimates have increased from $8.54 to $8.76 for 2018 and from $10.19 to $10.60 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 2.38%.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Japan Nods to AstraZeneca's Tagrisso for First-Line NSCLC
AstraZeneca (AZN - Free Report) announced that it has secured a Japanese approval for the label expansion of its marketed drug, Tagrisso (osimertinib) for first-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
A similar label expansion application was approved in the United States in April and in EU in June. Until now, Tagrisso was approved in the United States, European Union, Japan and China as a second-line treatment option for patients with EGFR mutation-positive NSCLC.
The first-line approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) 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 study 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.
Shares of AstraZeneca outperformed the industry year to date. The stock gained 11.9% compared with the industry’s gain of 5.6%.
During the second quarter of 2018, Tagrisso recorded sales of $422 million, up 77% year over year, driven by increased testing rates. On the call, the company said it saw an encouraging start to the first line launch in the United States., which contributed to sales growth.
The company said that Tagrisso achieved market leadership in new patient starts in the United States in the first-line setting. In Europe, Tagrisso was launched for the first-line indication in select EU countries, including in France and Germany. The approvals in Japan and EU should drive sales of Tagrisso higher in future quarters.
We note that Merck’s (MRK - Free Report) Keytruda is the only anti-PD-1 approved in the first-line lung cancer setting both as a monotherapy as well as combination therapy.
AstraZeneca PLC Price
AstraZeneca PLC Price | AstraZeneca PLC Quote
Zacks Rank and Stocks to Consider
AstraZeneca has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. (GILD - Free Report) and Celgene Corp. . While Gilead carries a Zacks Rank #1 (Strong Buy), Celgene carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.15 to $6.57 for 2018 and from $6.33 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 1.0% so far this year.
Celgene’s earnings per share estimates have increased from $8.54 to $8.76 for 2018 and from $10.19 to $10.60 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 2.38%.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>