AstraZeneca PLC (AZN - Free Report) announced that the European Commission has approved the label expansion of its lung cancer drug, Tagrisso (osimertinib). With this latest development, Tagrisso can be used for first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC), whose tumors have EGFR mutations.
Tagrisso was hitherto approved in the United States, European Union, Japan and China as a second-line treatment option for patients with EGFR mutation-positive NSCLC.
Earlier in April 2018, the FDA gave a nod to Tagrisso (osimertinib) in the first line setting.
The EU approval was expected as in April, the Committee for Medicinal Products for Human Use lent a positive opinion recommending approval of Tagrisso in the first-line setting.
The approval was based on encouraging 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. Tagrisso was well received in the trial with a safety profile, consistent with the previous studies.
In the first quarter of 2018, Tagrisso recorded sales of $338 million, up 89% year over year, driven by increased testing rates in the United States and Japan. This approval in the first line setting is likely to boost sales of Tagrisso in the coming quarters.
Apart from Tagrisso, AstraZeneca markets several cancer drugs like Imfinzi, Lynparza among others. The company markets Lynparza in partnership with Merck & Co., Inc. (MRK - Free Report) . Oncology sales now comprise almost 25% of AstraZeneca’s total product sales and the metric also rose 19% in 2017.
Shares of AstraZeneca have gained 4.9% year to date versus the industry’s decline of 3.7%.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Better-ranked stocks in the same sector include H Lundbeck A/S (HLUYY - Free Report) and Eli Lilly and Company (LLY - Free Report) . While H Lundbeck sports a Zacks Rank #1, Eli Lilly carries a Zacks Rank #2 (Buy).
H Lundbeck’s earnings per share estimates have been revised 11.6% upward for 2018 and 4.3% for 2019 in the last 60 days. The stock has substantially soared 40.8% year to date.
Eli Lilly and Company’s earnings per share estimates have risen 5.8% for 2018 and 3.2% for 2019 in the last 60 days. The stock has increased 2% year to date.
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