AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN) has received a recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for its drug Tagrisso.
This recommendation is for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) with specific EGFR mutations, who have not progressed during or after platinum-based chemoradiation therapy.
The CHMP's positive opinion, announced today, is based on results from the LAURA Phase III trial, which demonstrated that Tagrisso significantly extended median progression-free survival to over three years.
Specifically, the trial showed an 84% reduction in the risk of disease progression or death compared to placebo. Patients treated with Tagrisso had a median progression-free survival of 39.1 months versus 5.6 months for those on placebo.
While overall survival results are not yet mature and continue to be evaluated, the trial data has been pivotal in the CHMP's endorsement. In Europe, lung cancer diagnoses exceed 450,000 annually, with 10-15% of NSCLC patients presenting with EGFR mutations.
Tagrisso's recommendation for approval represents a significant advancement for nearly one in five NSCLC patients with unresectable tumors.
The safety profile of Tagrisso in the LAURA trial was consistent with its established profile, with no new safety concerns identified. The drug's approval for this indication in the EU follows a recent approval in the United States and is under review in other countries, including China and Japan.
Tagrisso is already approved in over 100 countries for various stages of EGFR-mutated NSCLC, both as a monotherapy and in combination with chemotherapy. AstraZeneca (NASDAQ:AZN) continues to explore its potential across all stages of this cancer type.
This information is based on a press release statement.
In other recent news, AstraZeneca has reported substantial growth in its financial performance, with a 21% increase in revenue and a 27% rise in core earnings per share (EPS) to $2.08 in the third quarter of 2024.
This strong performance has led the company to upgrade its full-year guidance, now forecasting high teens percentage growth in both total revenue and core EPS. In addition, AstraZeneca has announced a significant investment of $3.5 billion in U.S. manufacturing and research and development (R&D).
Recent developments also include significant share purchases by key figures within the company. AstraZeneca's Non-Executive Chair of the Board, Michel Demaré, acquired 2,000 ordinary shares, while CEO Pascal Soriot purchased 20,000 ordinary shares, and Philip Broadley, a Senior independent Non-Executive Director, bought 980 shares.
These transactions, often seen as signs of confidence in the company's prospects, were conducted in accordance with the EU Market Abuse Regulation.
On the sectoral front, AstraZeneca's Oncology revenues climbed by 22% to $16 billion, with significant contributions from Tagrisso and Calquence. The BioPharmaceuticals segment also saw substantial growth, with revenue reaching $15.9 billion, a 20% increase.
Despite a decrease in revenue from China, AstraZeneca remains optimistic about its long-term revenue target of $80 billion by 2030. These are the latest developments in the company's ongoing growth and investment strategy.
InvestingPro Insights
AstraZeneca's recent positive recommendation for Tagrisso aligns with its strong position in the pharmaceutical industry. According to InvestingPro data, the company boasts a substantial market capitalization of $193.72 billion, reflecting its significant presence in the market. The company's revenue growth of 13.81% over the last twelve months and 18.04% in the most recent quarter underscores its ability to expand its product portfolio and market reach.
InvestingPro Tips highlight that AstraZeneca is expected to grow its net income this year, which could be partly attributed to successful drug developments like Tagrisso. The company's profitability is further emphasized by its impressive gross profit margin of 82.61% in the last twelve months, indicating efficient cost management and strong pricing power for its innovative drugs.
Additionally, AstraZeneca has maintained dividend payments for 32 consecutive years, demonstrating its commitment to shareholder returns alongside its focus on research and development. This consistent dividend history, coupled with a current dividend yield of 1.55%, may appeal to income-focused investors.
For readers interested in a deeper analysis, InvestingPro offers 11 additional tips for AstraZeneca, providing a comprehensive view of the company's financial health and market position.
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