AstraZeneca AZN announced that its blockbuster cancer drug, Tagrisso (osimertinib), has been approved in the EU for expanded use in non-small cell lung cancer (NSCLC).

The eligible patient population includes adults with locally advanced, unresectable NSCLC with EGFR exon 19 deletions (ex19del) or exon 21 (L858R) substitution mutations whose disease has not progressed during or following platinum-based chemoradiation therapy. The FDA approved this combination in September for a similar indication.

The nod in the EU is based on data from the phase III LAURA study, which showed that treatment with Tagrisso reduced the risk of disease progression or death by 84% compared to placebo. Patients treated with the drug experienced a median progression-free survival of 39.1 months compared with 5.6 months for patients in the placebo group. The drugs’ safety and tolerability profiles were consistent with prior studies and no new safety concerns were identified.

Last month, the EMA’s advisory committee adopted a positive opinion, recommending the label expansion of AstraZeneca’s Tagrisso for the NSCLC indication. In the past three months, AstraZeneca’s shares have lost 15% compared with the industry’s 17.4% decline.

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Tagrisso is currently approved in the EU for four indications, all across different settings in the NSCLC indication. The drug is considered the current standard of care for EGFR-mutated NSCLC in the first-line setting.

Per AstraZeneca, more than 450,000 people in the EU are diagnosed with lung cancer annually. Of these, 80-85% have NSCLC, and 10-15% of NSCLC cases involve tumors with an EGFR mutation. Tagrisso's EU approval for the new NSCLC indication is its fifth major approval based on the LAURA study, following approvals in the United States, Switzerland, South Korea and Australia, with reviews ongoing in China, Japan and other countries.

Tagrisso - A Key Top-Line Driver for AZN

Tagrisso is approved in more than 100 countries worldwide, including the United States, the EU and Japan, for use in different NSCLC settings. In the first nine months of 2024, the drug added sales worth $4.9 billion to AstraZeneca’s top line, up 15% year over year. Sales of this drug have been rising, driven by strong demand as a first-line and adjuvant treatment.

AstraZeneca is also evaluating the drug in multiple-label expansion studies in lung cancer indications. This includes two late-stage studies, one evaluating the drug in the neoadjuvant setting and another in the early-stage adjuvant resectable setting. Continued label expansion for Tagrisso into additional indications and patient populations should boost drug sales in the future.

AstraZeneca PLC Price and Consensus

AstraZeneca PLC price-consensus-chart | AstraZeneca PLC Quote

AZN’s Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, 2024 estimates for Castle Biosciences have improved from a loss of 59 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.15 to $1.84. In the past three months, shares of Castle Biosciences have lost 5.9%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. In the past three months, CTMX stock has lost 8.4%.

CytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. In the past three months, Spero’s shares have lost 25.4%.

SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.

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