FDA approves TAGRISSO for stage III lung cancer

WILMINGTON, Del. - AstraZeneca (NASDAQ:AZN)'s TAGRISSO (osimertinib) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) that is unresectable and has not worsened during or after platinum-based chemoradiation therapy. This decision follows a Priority Review and is backed by outcomes from the LAURA Phase III trial.

The LAURA trial results, which were a focus of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and concurrently published in The New England Journal of Medicine, demonstrated that TAGRISSO reduced the risk of disease progression or death by 84% compared to a placebo. Specifically, median progression-free survival (PFS) was extended to 39.1 months from 5.6 months with a placebo.

In the United States, lung cancer diagnoses exceed 200,000 annually, with NSCLC accounting for 80-85% of these cases. Approximately 15% of these patients have EGFR mutations, and nearly one in five people with NSCLC present with an unresectable tumor. TAGRISSO is now approved for patients with exon 19 deletions or exon 21 (L858R) mutations as identified by an FDA-approved test.

Suresh Ramalingam, MD, the principal investigator in the trial, emphasized the significance of this approval for patients with Stage III EGFR-mutated lung cancer, noting the substantial extension of disease-free progression demonstrated in the LAURA trial.

Dave Fredrickson, Executive Vice President of AstraZeneca's Oncology Business Unit, highlighted the importance of this approval for patients who previously had no targeted therapy options. He underscored TAGRISSO's potential as a foundational treatment for EGFR-mutated NSCLC across all stages.

The safety profile of TAGRISSO in the LAURA trial was consistent with its known characteristics, and no new safety concerns were identified. It is also approved for first-line metastatic settings as a monotherapy and in combination with chemotherapy, and as an adjuvant treatment for early-stage disease. Regulatory reviews are underway in other countries for the same indication.

This information is based on a press release statement from AstraZeneca.

In other recent news, AstraZeneca's Tagrisso has gained FDA approval for a specific type of Stage III lung cancer, based on the results of the LAURA Phase III trial. Meanwhile, the TROPION-Breast01 Phase III trial reported mixed results, with significant improvement in progression-free survival but failing to meet statistical significance in overall survival rates. The FDA also approved AstraZeneca's FluMist influenza vaccine for home use, potentially increasing vaccination rates. Furthermore, Fasenra, another AstraZeneca drug, received FDA approval for the treatment of a rare immune-mediated vasculitis, eosinophilic granulomatosis with polyangiitis. The HIMALAYA Phase III trial reported extended survival of patients with unresectable hepatocellular carcinoma. On the analyst front, Deutsche Bank downgraded AstraZeneca stock due to concerns over the company's TROP2 asset datopotamab, while BMO Capital, Erste Group, TD Cowen, and BofA Securities maintained positive outlooks on AstraZeneca shares. These are recent developments in the ongoing advancements of AstraZeneca.

InvestingPro Insights

AstraZeneca's recent FDA approval for TAGRISSO marks a significant milestone in the treatment of NSCLC, potentially impacting the company's financial outlook. According to InvestingPro data, AstraZeneca boasts a robust market capitalization of $240.94 billion, reflecting investor confidence in its market position and pipeline. The company's revenue growth over the last twelve months as of Q2 2024 stands at an impressive 10.45%, indicating a strong financial performance amidst its latest clinical advancements.

InvestingPro Tips suggest that AstraZeneca is a prominent player in the Pharmaceuticals industry, with expectations of net income growth this year. Analysts have also revised their earnings upwards for the upcoming period, signaling optimism surrounding the company's financial prospects. Notably, AstraZeneca has maintained dividend payments for 32 consecutive years, which is a testament to its financial stability and commitment to shareholders.

With a high P/E ratio of 37.27 and a price/book ratio of 6.07, the stock is trading at a premium, which could be justified by its growth potential and established presence in the pharmaceutical sector. Interested investors can find 14 additional InvestingPro Tips on AstraZeneca, including insights into the company's debt levels and cash flow capabilities, by visiting https://www.investing.com/pro/AZN.

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