AZN's Imfinzi Wins EU Nod for Muscle-Invasive Bladder Cancer

AstraZeneca AZN announced that the European Commission has approved its blockbuster cancer drug, Imfinzi (durvalumab), for a bladder cancer indication in the European Union (EU).

The regulatory body in Europe has now approved Imfinzi in combination with gemcitabine and cisplatin as a neoadjuvant treatment for muscle-invasive bladder cancer (MIBC), followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy in adult patients.

Imfinzi EU Nod Based on AZN's NIAGARA Study Data

The latest approval was based on data from the phase III NIAGARA study.

Data from the study showed that treatment with an Imfinzi-based perioperative regimen led to a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm.

The study also demonstrated a 25% reduction in the risk of death in patients treated with the Imfinzi-based perioperative regimen versus the comparator arm.

The EU approval was expected, as the European Medicines Agency’s Committee for Medicinal Products for Human Use had rendered a positive opinion recommending approval of Imfinzi for the given indication in May.

The FDA approved Imfinzi for a similar indication based on data from the NIAGARA phase III study in March.

Regulatory applications seeking approval for Imfinzi in MIBC are under review in Japan and several other countries.

Year to date, shares of AstraZeneca have risen 6% against the industry’s decline of 1.4%.

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.

Imfinzi, either as a monotherapy or in combination with chemotherapy, is presently approved for stage III NSCLC, 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. The drug was also recently approved for limited-stage small cell lung cancer in the United States and the EU.

Several other label expansion studies on Imfinzi are currently underway, targeting other cancer indications.

Imfinzi remains a key revenue driver for AstraZeneca’s oncology portfolio. In the first quarter of 2025, Imfinzi generated sales of $1.26 billion, up 16% year-over-year, driven by demand growth in lung and liver cancer indications.

AZN's Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Exelixis EXEL, Spero Therapeutics SPRO and Puma Biotechnology PBYI, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.64 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.85 to $3.13. Year to date, shares of EXEL have rallied 38.6%.

EXEL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 48.60%.

In the past 60 days, estimates for Spero Therapeutics’ loss per share have narrowed from $2.32 to $1.43 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.98 to $1.15. Year to date, shares of SPRO have surged 182.6%.

SPRO’s earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, the average surprise being 8.29%.

In the past 60 days, estimates for Puma Biotechnology’s earnings per share have increased from 60 cents to 65 cents for 2025. During the same time, earnings per share estimates for 2026 have risen from 48 cents to 51 cents. Year to date, shares of PBYI have gained 17.4%.

PBYI’s earnings beat estimates in each of the trailing four quarters, the average surprise being 171.43%.

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