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AstraZeneca AZN recently announced that the European Commission has approved its blockbuster cancer drug Imfinzi (durvalumab) as monotherapy for treating limited-stage small cell lung cancer (LS-SCLC) in adult patients whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
The latest approval for Imfinzi in the European Union (EU) was based on data from the phase III ADRIATIC study.
Data from the phase III ADRIATIC study showed that treatment with Imfinzi reduced the risk of death by 27% as compared to placebo. Additionally, treatment with Imfinzi reduced the risk of disease progression or death by 24% versus placebo.
The approval in the EU was expected as the Committee for Medicinal Products for Human Use recommended approval of Imfinzi as monotherapy for treating LS-SCLC in adult patients whose disease has not progressed following platinum-based CRT in February 2025.
The FDA approved Imfinzi for a similar indication in December 2024.
In the past year, shares of AstraZeneca have rallied 17.8% against the industry’s decline of 7.3%.
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Imfinzi: A Key Revenue Driver for AZN
Imfinzi is the global standard of care in the curative-intent setting of unresectable, stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy. The drug is also approved for extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer, and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries.
Imfinzi is a key revenue driver for AZN’s oncology portfolio, having generated sales worth $4.72 billion in 2024. Sales rose 21% year over year at constant exchange rates, driven by demand growth across all approved indications.
Imfinzi is being evaluated for multiple cancers, either alone or in combination with other regimens, including phase III studies in earlier settings in NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynecologic cancers and other solid tumors.
AZN's Phase III CALYPSO Study on Eneboparatide Meets Primary Goal
In a separate press release, AstraZeneca announced that the phase III CALYPSO study evaluating its pipeline candidate, eneboparatide for treating chronic hypoparathyroidism in adults has met its primary endpoint of normalizing serum calcium levels in the given patient population.
Data from the CALYPSO study showed that treatment with eneboparatide, an investigational PTH receptor 1 agonist, led to statistical significance in adults with chronic hypoparathyroidism versus placebo at 24 weeks.