AstraZeneca PLC (LSE/STO/NASDAQ: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) for the treatment of adult patients with resectable early-stage (stage IIA-IIIB) non-small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements. Treatment involves the combination of Imfinzi with neoadjuvant chemotherapy prior to surgery, followed by adjuvant monotherapy.
The FDA’s decision is based on results from the Phase III AEGEAN study, which demonstrated a 32% reduction in the risk of disease recurrence or death compared to chemotherapy alone. These results were published in The New England Journal of Medicine in October 2023. The study also reported a pathologic complete response (pCR) rate of 17.2% with the Imfinzi regimen compared to 4.3% with chemotherapy alone.
Lung cancer remains the leading cause of cancer death globally, with an estimated 2.4 million diagnoses annually and approximately 235,000 new cases expected in the United States in 2024. Despite surgery and adjuvant chemotherapy, a high rate of recurrence is observed in patients with resectable disease, highlighting a major unmet medical need.
John V. Heymach, MD, PhD, of The University of Texas MD Anderson Cancer Center, emphasized the importance of this approval for patients, suggesting that Imfinzi should become a standard treatment for resectable NSCLC due to its significantly improved patient outcomes.
Dave Fredrickson, executive vice president of AstraZeneca, echoed this sentiment, underlining the company’s commitment to new approaches in the early stages of lung cancer.
The safety profile of Imfinzi was consistent with previous findings and no new problems were identified. The treatment did not affect patients’ ability to undergo surgery. Imfinzi is also approved in the UK, Switzerland and Taiwan and is under review in the EU, China and other countries.
Imfinzi has already established itself as a standard of care in the curative treatment of unresectable stage III NSCLC, following the success of the phase III PACIFIC study.
The information in this article is based on a press release.
In other recent news, AstraZeneca secured €1.4 billion through a bond offering led by BNP Paribas, Goldman Sachs International, Morgan Stanley and Societe Generale.
TD Cowen raised its price target on AstraZeneca shares to $95 from its previous target of $90, maintaining a Buy rating. The adjustment comes as the company revised its financial model for the company, forecasting above-average growth for the industry.
Additionally, AstraZeneca disclosed its total voting rights and share capital at the end of July, in accordance with the UK Financial Conduct Authority’s disclosure and transparency rules. These recent developments highlight AstraZeneca’s continued progress and achievements in the pharmaceutical industry.
InvestingPro Insights
The recent FDA approval of AstraZeneca’s Imfinzi for the treatment of early NSCLC marks a significant milestone for the company, potentially impacting its financial outlook. According to InvestingPro data, AstraZeneca (NASDAQ: AZN) has a solid market cap of $263.05 billion, reflecting its strong position in the pharmaceutical industry. The company’s revenue grew 10.45% over the trailing twelve months as of Q2 2024, indicating a healthy growth trajectory in its financial performance. Additionally, AstraZeneca maintained a gross profit margin of 82.62%, demonstrating its ability to retain a substantial portion of revenue after accounting for cost of goods sold.
InvestingPro’s recommendations suggest that AstraZeneca is expected to post net profit growth this year, which could be further boosted by the new FDA approval and subsequent sales of Imfinzi. However, it is important to note that four analysts have lowered their earnings estimates for the coming period, which could indicate potential challenges ahead. Investors should be aware that the stock is currently trading at a high P/E ratio of 40.75, which could suggest that the market has high expectations for future earnings growth. For those interested in diving deeper into AstraZeneca’s stock performance and future prospects, here are 17 more recommendations InvestingPro su
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