AstraZeneca's (AZN) Lung Cancer Drug Gets Full FDA Approval

AstraZeneca plc (NYSE:AZN) announced that its lung cancer drug, Tagrisso has received full approval from the FDA.

We remind investors that Tagrisso had earlier received accelerated approval in 2015. The approval of the drug will help it to become a standard 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. Tagrisso is now the only approved drug available in the U.S. for NSCLC patients with EGFR T790 mutation.

Shares of AstraZeneca have risen 14% since the beginning of this year, outperforming the Zacks classified Large Cap Pharmaceuticals industry, which increased 6% in the same period.

Full approval of the drug is based on positive data from the phase III study AURA3 trial

Data from the study demonstrated statistically-significant improvement in progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The data showed that treatment with Tagrisso reduced risk of disease progression by 70% and improved median progression-free survival (PFS) by 10.1 months compared to of 4.4 months in patients treated with platinum-based doublet chemotherapy.

The trial results were presented at the 17th World Conference on Lung Cancer.

The drug is designed to stop the mutation in virus and prevent it from becoming treatment resistant. Patients are treated with Tagrisso only if they are diagnosed with EGFR T790M mutation in the tumor. Meanwhile, Tagrisso is also being investigated for the 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.

According to the data presented in the press release, lung cancer is a major cause of deaths due to cancer in both men and women. As per the numbers, 15-20% of the patients in the U.S. and Europe with NSCLC are diagnosed with EGFR mutation and approximately two-thirds of these patients develop T790 mutation after initial EGFR TKI therapy.

We are encouraged by the full approval of Tagrisso in the U.S. 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.

We remind investors that Roche Holding (SIX:ROG) AG (OTC:RHHBY) 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.

Zacks Rank & Picks

AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) and Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) . Corvus sports a Zacks Rank #1 (Strong Buy) while Vertex carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Vertex have risen 48.4% this year so far while earnings estimates for 2017 have gone up by almost 4% in the past 30 days.

Corvus’ loss estimates narrowed from $3.64 to $3.35 for 2017 over the last 60 days. Shares of the company have risen 45.4% since the beginning of this year.

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