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AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN), a pharmaceutical giant with a market capitalization of $223 billion and an impressive 82% gross profit margin according to InvestingPro, announced today that its drug Imfinzi (durvalumab), combined with chemotherapy, has received approval from the European Union for the treatment of adult patients with a specific form of lung cancer. The company, which has maintained dividend payments for 33 consecutive years, continues to demonstrate its strength in the pharmaceutical sector. This new therapy is aimed at patients with resectable non-small cell lung cancer (NSCLC) who are at high risk of recurrence and do not have EGFR mutations or ALK rearrangements.
The European Commission’s decision is based on the results of the AEGEAN Phase III trial, which demonstrated a 32% reduction in the risk of disease recurrence, progression, or death compared to neoadjuvant chemotherapy alone. The trial’s findings were published in The New England Journal of Medicine. This development adds to AstraZeneca (NASDAQ:AZN)’s strong performance, with the company reporting an 18% year-over-year revenue growth to $54.1 billion in the last twelve months.
In Europe, lung cancer diagnoses exceed 450,000 annually, with 25-30% of NSCLC patients eligible for potentially curative surgery. Despite this, recurrence rates remain high, with only 36-46% of Stage II patients and even fewer with advanced stages surviving five years post-diagnosis, highlighting a significant unmet medical need.
The approval is particularly noteworthy as it introduces a new perioperative treatment regimen, where Imfinzi is administered with chemotherapy before surgery and as a standalone therapy after surgery.
Professor Martin Reck, a member of the AEGEAN Steering Committee, emphasized the importance of this approval for patients in Europe, stating that the combination of durvalumab and neoadjuvant chemotherapy could become a standard approach for this patient group.
AstraZeneca’s Executive Vice President, Dave Fredrickson, also commented on the approval, indicating it as a step forward in improving outcomes for European patients with resectable NSCLC and highlighting AstraZeneca’s commitment to early-stage lung cancer treatment.
The AEGEAN trial’s interim analysis showed a significant extension in event-free survival for patients treated with the Imfinzi-based regimen. Additionally, the treatment was well tolerated, and no new safety concerns were identified.
Imfinzi is already approved in the US, China, and other countries for this indication, with ongoing reviews in Japan and elsewhere. The drug is also established as the global standard of care in unresectable, Stage III NSCLC based on the PACIFIC Phase III trial.
This recent approval adds to AstraZeneca’s portfolio in lung cancer treatment and reflects the company’s broader strategy to redefine cancer care and pursue cures for different forms of the disease. The information is based on a press release statement. While InvestingPro analysis suggests the stock is currently trading above its Fair Value, investors can access detailed financial health metrics, 8 additional ProTips, and comprehensive valuation analysis through InvestingPro’s detailed research reports, available for over 1,400 US stocks including AstraZeneca.
In other recent news, AstraZeneca has announced several significant developments. The company’s drug Enhertu received approval from the European Union for treating a specific type of metastatic breast cancer, following positive results from the DESTINY-Breast06 Phase III trial. This approval will result in a $125 million milestone payment to Daiichi Sankyo, AstraZeneca’s partner in developing Enhertu. In another development, AstraZeneca’s experimental drug AZD0780 showed promising results in a Phase IIb clinical trial, significantly reducing LDL cholesterol levels when added to standard statin therapy. Additionally, AstraZeneca’s Calquence has been recommended for approval by the European Medicines Agency’s CHMP as a first-line treatment for mantle cell lymphoma, based on the ECHO Phase III trial results. Meanwhile, the FDA has approved AstraZeneca’s Imfinzi as a perioperative treatment for muscle-invasive bladder cancer, marking it as the first immunotherapy for this condition. This approval was based on the NIAGARA Phase III trial, which demonstrated significant improvements in survival rates. Lastly, AstraZeneca reported its total number of voting rights, confirming 1,550,623,487 ordinary shares, which serves as a reference for shareholders under regulatory requirements.
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