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WILMINGTON, Del. - AstraZeneca’s IMFINZI (durvalumab) in combination with FLOT chemotherapy has received FDA approval for treating adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers, the company announced. This approval adds to the portfolio of the $287.86 billion pharmaceutical giant, which InvestingPro identifies as a prominent player in the pharmaceuticals industry. The company’s stock is currently trading near its 52-week high of $93.41, reflecting investor confidence in its pipeline developments.
The approved regimen includes IMFINZI with chemotherapy before surgery (neoadjuvant), followed by the same combination after surgery (adjuvant), then IMFINZI alone. The FDA granted Priority Review based on results from the Phase III MATTERHORN trial.
The trial demonstrated that patients treated with the IMFINZI regimen showed a 29% reduction in the risk of progression, recurrence or death compared to chemotherapy alone. Additionally, the IMFINZI-based treatment reduced the risk of death by 22%.
"Nearly seven in 10 patients were alive at three years following treatment with the durvalumab-based perioperative regimen," said Dr. Yelena Y. Janjigian, principal investigator and Chief Attending Physician at Memorial Sloan Kettering Cancer Center. "This survival benefit, observed regardless of PD-L1 status, establishes a new standard of care in this curative-intent setting."
Gastric cancer ranks as the fifth leading cause of cancer death globally, with nearly one million diagnoses annually. In 2024, approximately 6,500 patients in the US were treated for early-stage and locally advanced gastric or GEJ cancer.
The safety profile for the IMFINZI and FLOT combination was consistent with the known profiles of each medicine. Grade 3 or higher adverse events were similar between the treatment arm (71.6%) and the chemotherapy-only arm (71.2%).
Regulatory applications for the same indication are under review in several other countries, including Australia, Canada, Switzerland, the European Union, and Japan.
This information is based on a press release statement from AstraZeneca.
In other recent news, AstraZeneca has received approval from the US Food and Drug Administration for Imfinzi, in combination with FLOT chemotherapy, as a treatment for early-stage gastric and gastroesophageal junction cancers. This approval was supported by the Phase III MATTERHORN trial, which demonstrated significant reductions in disease progression and mortality. Additionally, AstraZeneca’s Koselugo has also been approved by the FDA for treating adults with neurofibromatosis type 1, following positive results from the KOMET Phase III trial.
BofA Securities has raised AstraZeneca’s stock price target to $108.50, maintaining a Buy rating, and included the company in its Europe 1 list of top ideas. AstraZeneca is also planning a substantial $2 billion investment to expand its Maryland manufacturing sites, which will nearly double production capacity and create 300 new jobs. The expansion will support the production of existing medicines and the company’s rare disease portfolio.
In corporate developments, AstraZeneca’s Chief Financial Officer, Aradhana Sarin, sold 15,000 American Depositary Shares on the Nasdaq exchange. This transaction was disclosed in compliance with EU Market Abuse Regulation. These recent developments highlight AstraZeneca’s ongoing strategic initiatives and regulatory achievements.
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