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AstraZeneca's Lung Cancer Drug Tagrisso Approved in China

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AstraZeneca plc (AZN - Free Report) announced that its lung cancer drug, Tagrisso has received approval in China.

The China Food and Drug Administration (CFDA) approved Tagrisso for the treatment of EGFR T790M mutation-positive, locally-advanced or metastatic non-small cell lung cancer (NSCLC) in adults, whose disease had progressed following first-line EGFR tyrosine kinase inhibitor (TKI) therapy.

Tagrisso, a third generation, irreversible EGFR inhibitor, is now available in more than 45 countries across the globe including the U.S., EU, Japan and China.

The drug is designed to prevent EGFR sensitising and also stops the mutation in virus, which makes it resistant to treatment. The drug supports activity in the central nervous system (CNS) of the patient. Patients are treated with Tagrisso only if they are diagnosed with EGFR T790M mutation in the tumor. Meanwhile, Tagrisso is also being investigated for treatment of adjuvant and metatstatic first line settings patients, with and without brain metastases. It is also being tested for the treatment of leptomeningeal disease and as combination therapies.

Shares of AstraZeneca have risen 14.5% since the beginning of this year, outperforming the Zacks classified Large Cap Pharmaceuticals industry, which increased 6.1% in the same period.

According to the studies, lung cancer is a major cause of deaths due to cancer in China. As per the numbers, 30-40% of the patients with NSCLC are diagnosed with EGFR mutation and two-thirds of these patients develop T790 mutation after initial EGFR TKI therapy. The EGFR mutation rates are some of the highest in China, which creates a significant opportunity for AstraZeneca. The drug is approved under priority review pathway, which also signals high occurrence and unavailability of treatment for the T790 mutation.

We are encouraged by the approval of Tagrisso in China. Uptake of the drug among patients worldwide is increasing steadily. Tagrisso earned revenues of $423 million worldwide in 2016. In the fourth quarter of 2016, the drug recorded sales of $147 million, increasing 10.5% sequentially. China is already the second largest market for AstraZeneca globally, bringing in revenues of $2.6 billion in 2016.

We remind investors that Roche Holding AG (RHHBY - Free Report) had developed a diagnostic test to identify NSCLC patients with a T790M mutation and are eligible for treatment with Tagrisso. The test was approved by the FDA in Nov 2015.

AstraZeneca is working on strengthening its oncology product portfolio and has several candidates in its pipeline. The company’s target is to launch at least six new medicines between 2014 and 2020.

Zacks Rank & Picks

AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anthera Pharmaceuticals, Inc. (ANTH - Free Report) and Corvus Pharmaceuticals, Inc. (CRVS - Free Report) . Both stocks sport a Zacks Rank #1 (Strong Buy).

Anthera’s loss estimates narrowed from $1.49 to 63 cents for 2017 over the last 60 days.

Corvus’ loss estimates narrowed from $3.64 to $3.35 for 2017 over the last 60 days. The shares of the company have risen 46.2% since the beginning of this year.

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