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AstraZeneca's Imfinzi Secures Approval for Gastric Cancer in the EU
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Key Takeaways
AstraZeneca secured EU approval for Imfinzi plus FLOT in early-stage gastric and GEJ cancers.
AZN's phase III MATTERHORN study showed improved survival and a 29% lower disease progression risk.
Imfinzi generated $6.1B in 2025 sales, rising 28% at CER on strong demand across indications.
AstraZeneca (AZN - Free Report) announced that the European Commission (EC) has approved its blockbuster cancer drug Imfinzi (durvalumab) as a perioperative treatment for early gastric and gastroesophageal junction (GEJ) cancers. Imfinzi is approved in combination with standard-of-care fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy for the treatment of adult patients with resectable, early-stage and locally advanced GEJ cancers. With this approval, Imfinzi becomes the first and only perioperative immunotherapy for patients with early GEJ cancers in the European Union (EU).
Perioperative therapy refers to treatment before and after surgery to improve outcomes, also known as neoadjuvant/adjuvant therapy.
The drug is already approved in the United States in combination with FLOT chemotherapy for this indication, with regulatory reviews ongoing in Japan and additional countries.
Year to date, shares of AstraZeneca have rallied 4.5% compared with the industry’s 3.7% growth.
Image Source: Zacks Investment Research
Phase III MATTERHORN Study Underpins the EU Approval of AZN’s Imfinzi
The EC approval was based on data from the global phase III MATTERHORN study, which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival (OS).
Treatment with the Imfinzi-based perioperative regimen demonstrated a 29% reduction in the risk of disease progression, recurrence, or death versus chemotherapy alone. In the final OS analysis, the Imfinzi plus FLOT regimen demonstrated a significant survival benefit, lowering the risk of death by 22%.
The approval was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion in February, recommending the approval of Imfinzi for this indication.
Imfinzi: A Key Revenue Driver for AZN
AstraZeneca’s Imfinzi has established a broad global footprint across multiple tumor types and treatment settings. In gastrointestinal (GI) cancers, it is approved in combination regimens for locally advanced or metastatic biliary tract cancer and unresectable hepatocellular carcinoma (HCC). The drug is also approved as a monotherapy for HCC in some countries.
Beyond GI indications, Imfinzi is a standard of care for unresectable Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy and is also approved in combination regimens for resectable and metastatic NSCLC. Additionally, it is approved for both limited-stage and extensive-stage small cell lung cancer in appropriate combination regimens.
The drug also holds approvals in bladder cancer, including perioperative use in muscle-invasive disease, and has demonstrated positive late-stage outcomes in non-muscle-invasive disease. Imfinzi is approved in combination-based regimens for the treatment of advanced or recurrent endometrial cancer in select markets.
Imfinzi is a key revenue driver for AZN’s oncology portfolio, having generated sales worth $6.1 billion in 2025. Sales rose 28% year over year at constant exchange rates, driven by demand growth across all approved indications.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.82. CPRX shares have gained 5.5% over the past year.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.11 to $1.06. CSTL shares have risen 26.1% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $8.14 to $8.72 for 2026. Over the past year, shares of ANIP have surged 12.3%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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AstraZeneca's Imfinzi Secures Approval for Gastric Cancer in the EU
Key Takeaways
AstraZeneca (AZN - Free Report) announced that the European Commission (EC) has approved its blockbuster cancer drug Imfinzi (durvalumab) as a perioperative treatment for early gastric and gastroesophageal junction (GEJ) cancers. Imfinzi is approved in combination with standard-of-care fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy for the treatment of adult patients with resectable, early-stage and locally advanced GEJ cancers. With this approval, Imfinzi becomes the first and only perioperative immunotherapy for patients with early GEJ cancers in the European Union (EU).
Perioperative therapy refers to treatment before and after surgery to improve outcomes, also known as neoadjuvant/adjuvant therapy.
The drug is already approved in the United States in combination with FLOT chemotherapy for this indication, with regulatory reviews ongoing in Japan and additional countries.
Year to date, shares of AstraZeneca have rallied 4.5% compared with the industry’s 3.7% growth.
Image Source: Zacks Investment Research
Phase III MATTERHORN Study Underpins the EU Approval of AZN’s Imfinzi
The EC approval was based on data from the global phase III MATTERHORN study, which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival (OS).
Treatment with the Imfinzi-based perioperative regimen demonstrated a 29% reduction in the risk of disease progression, recurrence, or death versus chemotherapy alone. In the final OS analysis, the Imfinzi plus FLOT regimen demonstrated a significant survival benefit, lowering the risk of death by 22%.
The approval was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion in February, recommending the approval of Imfinzi for this indication.
Imfinzi: A Key Revenue Driver for AZN
AstraZeneca’s Imfinzi has established a broad global footprint across multiple tumor types and treatment settings. In gastrointestinal (GI) cancers, it is approved in combination regimens for locally advanced or metastatic biliary tract cancer and unresectable hepatocellular carcinoma (HCC). The drug is also approved as a monotherapy for HCC in some countries.
Beyond GI indications, Imfinzi is a standard of care for unresectable Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy and is also approved in combination regimens for resectable and metastatic NSCLC. Additionally, it is approved for both limited-stage and extensive-stage small cell lung cancer in appropriate combination regimens.
The drug also holds approvals in bladder cancer, including perioperative use in muscle-invasive disease, and has demonstrated positive late-stage outcomes in non-muscle-invasive disease. Imfinzi is approved in combination-based regimens for the treatment of advanced or recurrent endometrial cancer in select markets.
Imfinzi is a key revenue driver for AZN’s oncology portfolio, having generated sales worth $6.1 billion in 2025. Sales rose 28% year over year at constant exchange rates, driven by demand growth across all approved indications.
AZN’s Zacks Rank & Stocks to Consider
AZN currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and Castle Biosciences (CSTL - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals (ANIP - Free Report) presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.82. CPRX shares have gained 5.5% over the past year.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.11 to $1.06. CSTL shares have risen 26.1% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $8.14 to $8.72 for 2026. Over the past year, shares of ANIP have surged 12.3%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.