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AstraZeneca PLC (LSE/STO/NASDAQ: LON:AZN) announced today that the U.S. Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements. The therapy involves a combination of Imfinzi with neoadjuvant chemotherapy before surgery and subsequent adjuvant monotherapy.
The FDA's decision is based on the results from the AEGEAN Phase III trial, which demonstrated a 32% decrease in the risk of disease recurrence or death compared to chemotherapy alone. These findings were published in The New England Journal of Medicine in October 2023. The trial also reported a pathologic complete response (pCR) rate of 17.2% for the Imfinzi regimen versus 4.3% with chemotherapy alone.
Lung cancer remains the leading cause of cancer death globally, with an estimated 2.4 million diagnoses each year and approximately 235,000 new cases expected in the U.S. in 2024. Despite surgery and adjuvant chemotherapy, a high recurrence rate is observed in patients with resectable disease, highlighting a significant unmet medical need.
John V. Heymach, MD, PhD, from 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 significant improvement in patient outcomes.
Dave Fredrickson, Executive Vice President at AstraZeneca (NASDAQ:AZN), echoed this sentiment, highlighting the company's commitment to novel approaches in early lung cancer settings.
The safety profile of Imfinzi was consistent with previous findings, and no new concerns were identified. The treatment did not affect the ability of patients to undergo surgery. Imfinzi is also approved in the UK, Switzerland, Taiwan, and is under review in the EU, China, and other countries.
Imfinzi is already established as the standard of care in the curative-intent setting of unresectable, Stage III NSCLC, following the success of the PACIFIC Phase III trial.
The information in this article is based on a press release statement.
In other recent news, AstraZeneca has secured €1.4 billion through a bond offering managed by BNP Paribas (OTC:BNPQY), Goldman Sachs International, Morgan Stanley, and Société Générale.
TD Cowen raised its stock price target on AstraZeneca's shares to $95 from the previous target of $90, maintaining a Buy rating. This adjustment comes as the firm revisited its financial model for the company, projecting growth that surpasses the industry average.
Furthermore, AstraZeneca disclosed its total number of voting rights and share capital as of the end of July, in compliance with the UK's Financial Conduct Authority's Disclosure and Transparency Rules. These recent developments highlight the ongoing advances and achievements of AstraZeneca in the pharmaceutical industry.
InvestingPro Insights
The recent FDA approval of AstraZeneca's Imfinzi for early-stage NSCLC marks a significant milestone for the company, potentially impacting its financial outlook. According to InvestingPro data, AstraZeneca (NASDAQ: AZN) has a robust market capitalization of $263.05 billion, reflecting its strong position in the pharmaceutical industry. The company's revenue has grown by 10.45% over the last twelve months as of Q2 2024, indicating a healthy upward trajectory in its financial performance. Moreover, AstraZeneca has maintained a gross profit margin of 82.62%, showcasing its ability to retain a substantial portion of its revenue after accounting for the cost of goods sold.
InvestingPro Tips suggest that AstraZeneca is expected to see net income growth this year, which could be further bolstered by the new FDA approval and subsequent sales of Imfinzi. However, it is also important to note that four analysts have revised their earnings estimates downwards for the upcoming period, which may 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 the market has high expectations for future earnings growth. For those interested in exploring more about AstraZeneca's stock performance and future outlook, there are an additional 17 InvestingPro Tips available at https://www.investing.com/pro/AZN.
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