FDA approves AstraZeneca’s IMFINZI for bladder cancer

WILMINGTON, Del. - The U.S. Food and Drug Administration (FDA) has approved AstraZeneca’s IMFINZI® (durvalumab) combined with gemcitabine and cisplatin for the neoadjuvant treatment of adult patients with muscle-invasive bladder cancer (MIBC), followed by IMFINZI as a monotherapy after surgery. This approval, which follows a Priority Review designation, is based on the Phase III NIAGARA trial results. AstraZeneca, with a market capitalization of $225 billion and recognized by InvestingPro as a prominent player in the Pharmaceuticals industry, has maintained strong financial health with an impressive 82% gross profit margin.

The NIAGARA trial, presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine, demonstrated a 32% reduction in the risk of disease recurrence and a 25% reduction in the risk of death compared to neoadjuvant chemotherapy alone. The trial included a regimen of four cycles of IMFINZI with neoadjuvant chemotherapy before radical cystectomy, followed by eight cycles of IMFINZI monotherapy. This development contributes to AstraZeneca’s robust 18% year-over-year revenue growth. For detailed analysis and more insights, investors can access the comprehensive Pro Research Report available on InvestingPro, which covers this and over 1,400 other top stocks.

Matthew ND. Galsky, a key investigator in the NIAGARA trial, highlighted the significance of this approval, stating it could transform care for patients with MIBC, a group that has historically faced high recurrence rates despite surgery with curative intent.

In 2024, more than 20,000 people in the U.S. were treated for MIBC, a form of bladder cancer characterized by tumor invasion into the bladder muscle. The current standard of care involves chemotherapy and radical cystectomy, but disease recurrence remains a significant challenge. AstraZeneca’s strong market position and financial stability, evidenced by its "GREAT" Financial Health Score from InvestingPro, positions it well to address this significant medical need. The company currently trades at a premium to its Fair Value, reflecting market confidence in its growth potential.

The NIAGARA trial’s key secondary endpoint of overall survival also showed promising results, with an estimated 82.2% of patients treated with the IMFINZI-based regimen alive at two years, in contrast to 75.2% in the comparator arm.

IMFINZI’s safety profile was consistent with previous findings, with no new safety signals observed. Immune-mediated adverse events were manageable and mostly low-grade.

In February 2025, the NCCN Clinical Practical Guidelines in Oncology recommended the perioperative treatment with durvalumab, neoadjuvant cisplatin-based chemotherapy, and cystectomy as a Category 1 regimen for patients with MIBC. Additionally, IMFINZI is approved in Brazil and under review in the EU, Japan, and several other countries.

This approval marks a significant advancement in the treatment of MIBC, offering a new standard of care for patients in the U.S. The information contained in this article is based on a press release statement.

In other recent news, AstraZeneca’s drug Imfinzi has received approval in the United States for treating muscle-invasive bladder cancer. This approval allows Imfinzi to be used alongside gemcitabine and cisplatin as a neoadjuvant treatment and as an adjuvant monotherapy after radical cystectomy, reducing the risk of death by 25% compared to chemotherapy alone. Goldman Sachs has maintained its Conviction Buy rating on AstraZeneca, setting a price target of $98.00, citing the potential of the company’s oral PCSK9 inhibitor, AZD0780. The Phase 2 PURSUIT trial data for AZD0780 is anticipated at the American College of Cardiology meeting in March 2025, which could influence the competitive landscape for cardiovascular drugs. Additionally, AstraZeneca’s stock target was slightly increased to £151.30 by Goldman Sachs, highlighting the growth potential in the oral PCSK9 inhibitor market. Meanwhile, drugmakers, including those in Europe, are accelerating shipments to the U.S. due to potential tariff threats from President Donald Trump, using services like UPS and DHL for faster deliveries. AstraZeneca’s CEO, Pascal Soriot, has also remarked on China’s rapid progress in pharmaceutical innovation, suggesting it may soon outpace Europe. Soriot praised China’s support for AstraZeneca’s new $2.5 billion research center in Beijing, highlighting the country’s openness to international pharmaceutical investment.

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