AstraZeneca Gains FDA Approval for Imfinzi in Stomach Cancer
The regulator approved the blockbuster drug as the first immunotherapy for early-stage gastric cancer patients before and after surgery, opening a significant new market.
AstraZeneca PLC (NASDAQ: AZN) has secured a significant new approval from the U.S. Food and Drug Administration (FDA) for its blockbuster cancer drug, Imfinzi, expanding its use to treat early-stage gastric and gastroesophageal junction (GEJ) cancers. The decision makes Imfinzi the first and only immunotherapy approved for use both before and after surgery in this setting, a milestone that analysts project could add nearly a billion dollars in peak sales.
Shares of AstraZeneca traded higher on the news, climbing 0.23% to $93.45 in morning trading, touching a new 52-week high. The approval further solidifies the British pharmaceutical giant's dominance in the highly competitive oncology market.
The FDA's decision clears Imfinzi, in combination with chemotherapy, for the perioperative treatment of adult patients with resectable, early-stage forms of these stomach-related cancers. The term "perioperative" refers to treatment administered before surgery (neoadjuvant) to shrink tumors and after surgery (adjuvant) to eliminate remaining cancer cells and reduce the risk of recurrence.
This approval was based on compelling results from the global Phase 3 MATTERHORN trial. Data from the study demonstrated that the Imfinzi-based regimen led to a statistically significant improvement in event-free survival compared to chemotherapy alone. According to the company's press release, patients treated with the Imfinzi combination saw a 29% reduction in the risk of disease progression or death.
"The approval of Imfinzi for early-stage gastric cancer is a meaningful advance for patients who have long faced low survival rates," said Dave Fredrickson, Executive Vice President of the Oncology Business Unit at AstraZeneca. "We are proud to offer the first immunotherapy regimen in the perioperative setting, a treatment framework that can significantly improve patient outcomes."
Gastric cancer is the fifth most common cancer worldwide, and despite treatment advances, the five-year survival rate for patients with resectable disease remains challenging. By introducing immunotherapy earlier in the treatment timeline, AstraZeneca aims to tackle the cancer when the immune system is more intact and responsive, potentially preventing it from returning after surgery.
The financial implications are substantial. Imfinzi is already a cornerstone of AstraZeneca's oncology portfolio, generating billions in revenue from its approved uses in lung and bladder cancer. Analysts have projected this new indication for gastric and GEJ cancers could contribute an additional $900 million in peak annual sales, further fueling the drug's growth trajectory. The consensus rating for AZN stock remains a 'Moderate Buy' among Wall Street analysts, as reported by Morningstar, although some technical indicators suggest the stock may be overbought after its recent run-up.
The approval also positions AstraZeneca ahead of key rivals in the immunotherapy space, such as Merck's Keytruda and Bristol Myers Squibb's Opdivo, by carving out a first-mover advantage in this specific perioperative niche for stomach cancers. The company continues to explore Imfinzi's potential across a wide range of tumors and treatment settings, with numerous ongoing clinical trials aimed at further broadening its impact.