AstraZeneca AZN announced that the FDA has approved its blockbuster drug, Tagrisso (osimertinib) for expanded use in lung cancer.

The regulatory body has approved Tagrisso for the treatment of unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) in adult patients whose disease has not progressed following treatment with chemoradiotherapy.

Following the latest nod, Tagrisso is now indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations, as determined by an FDA-approved test.

Year to date, shares of AstraZeneca have gained 15.1% compared with the industry’s rise of 22.8%.

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Tagrisso Latest Approval Based on AZN's LAURA Study

The latest label expansion nod for Tagrisso was based on data from the phase III LAURA study. Data from the study showed that treatment with Tagrisso reduced the risk of disease progression or death by 84% versus placebo.

Also, patients treated with Tagrisso experienced a median progression-free survival of 39.1 months compared with 5.6 months for patients who were treated with a placebo.

Overall survival, which is a secondary endpoint of the LAURA study, remains immature in the current analysis.

Tagrisso, in combination with chemotherapy for treating frontline EGFR mutated NSCLC, was approved by the FDA in February 2024. This approval was based on data from the FLAURA2 study. The European Commission approved Tagrisso for a similar indication in July 2024.

Tagrisso – A Key Revenue Driver for AZN

Currently, Tagrisso is approved as a monotherapy for the first-line treatment of EFGR-mutated NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC and adjuvant treatment of early-stage EGFRm NSCLC. The drug is the current standard of care in the first-line setting.

Tagrisso has been one of the key revenue drivers for AstraZeneca.

In the first half of 2024, Tagrisso recorded sales worth $3.2 billion, increasing 13% year over year at constant exchange rates, on strong demand as a first-line and adjuvant treatment. Label expansion of the drug in later line settings is likely to boost sales further in the upcoming quarters.

AZN's Zacks Rank & Other Stocks to Consider

AstraZeneca currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. ANIP, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, 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, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 3.9%.

ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.

In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $2.09 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 44.7%.

KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.

In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 50.2%.

FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.

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