AZN Gets CHMP Nod for Imfinzi in Muscle-Invasive Bladder Cancer

AstraZeneca AZN announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending the approval of its blockbuster cancer drug, Imfinzi (durvalumab), for a bladder cancer indication in the European Union (EU).

The CHMP recommended the approval of 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.

The positive CHMP opinion was based on data from the phase III NIAGARA study. Data from the same 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 FDA approved Imfinzi for a similar indication based on data from the NIAGARA phase III study in March.

The FDA nod marked the first time an immunotherapy regimen has been approved in a perioperative setting, which makes Imfinzi a potential transformative option for the MIBC patient population.

AZN Stock Price Performance

Year to date, shares of AstraZeneca have risen 7.5% against the industry’s decline of 5.7%.

AZN Ongoing Developments With Imfinzi: Key Revenue Driver

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

Besides the EU, regulatory applications seeking approval for Imfinzi in MIBC are under review in Japan and several other countries.

Earlier this month, AZN announced data from the phase III POTOMAC study, evaluating one year of treatment with Imfinzi plus standard of care (SOC), Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer.

In the study, the Imfinzi regimen demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the given patient population compared to BCG induction and maintenance therapy alone.

Overall, the data showed that adding one year of Imfinzi to the current SOC treatment significantly extended the time patients live without high-risk disease recurrence or progression.

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%, 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 Halozyme Therapeutics HALO, Lexicon Pharmaceuticals LXRX and Amarin AMRN, 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 Halozyme’s earnings per share have increased from $5.01 to $5.23 for 2025. During the same time, earnings per share estimates for 2026 have increased from $6.54 to $6.77. Year to date, shares of HALO have risen 14.1%.

HALO’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 17.60%.

In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 10.7%.

LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.

In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 14.5%.

AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.

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