AstraZeneca AZN and partner Daiichi Sankyo announced that the European Commission has approved the expanded use of Enhertu (trastuzumab deruxtecan) in breast cancer.

The regulatory body has now approved Enhertu as a monotherapy for treating metastatic HR-positive, HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for the therapy as the next line of treatment in the European Union (“EU”).

The latest nod in the EU expands the approved indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow.

Enhertu was approved for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer in the United States in January based on data from the DESTINY-Breast06 study.Similar regulatory filings based on the DESTINY-Breast06 study data are currently under review in Japan and several other countries.

Year to date, shares of AstraZeneca have risen 4.5% against the industry’s decrease of 5.8%.

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EU Nod for Enhertu Based on AZN's DESTINY-Breast06 Study Data

The latest EC approval was based on positive data from the phase III DESTINY-Breast06 study, which compared Enhertu with chemotherapy.

The approval in the EU was expected as the Committee for Medicinal Products for Human Use recommended approval of Enhertu for the given indication in February 2025.

Treatment with Enhertu in patients with HER2-low expression led to a progression-free survival of 13.2 months compared with 8.1 months for chemotherapy in the overall patient population. This was the primary endpoint of the study.

Enhertu, a specifically engineered HER2-directed antibody-drug conjugate, is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

The drug is presently approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer, metastatic HER2-positive and HER2-low breast cancer, and solid tumors.

AZN Gets Imfinzi Label Expansion Nod in EU

In a separate press release, AstraZeneca announced that the EC has approved expanded use of its blockbuster cancer drug Imfinzi (durvalumab) in non-small cell lung cancer (“NSCLC”).

The regulatory body in Europe has now approved Imfinzi in combination with chemotherapy for treating adults with resectable NSCLC with no known EGFR mutations or ALK rearrangements. In this regimen, Imfinzi, in combination with neoadjuvant chemotherapy, is administered before surgery and as adjuvant monotherapy after surgery.

The approval in the EU was expected as the Committee for Medicinal Products for Human Use recommended approval of Imfinzi for the given indication last month.

This approval was based on data from the phase III AEGEAN study, which showed that treatment with an Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% in resectable early-stage NSCLC patients compared with chemotherapy alone.

The FDA approved Imfinzi for a similar indication in August 2024.

Imfinzi is the global standard of care in the curative-intent setting of unresectable, stage III non-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.

AZN's Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. JAZZ, Dynavax Technologies Corporation DVAX and Krystal Biotech, Inc. KRYS, 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 Jazz Pharmaceuticals’ earnings per share have increased from $22.03 to $23.33 for 2025. During the same time, earnings per share estimates for 2026 have increased from $23.13 to $23.35. Year to date, shares of JAZZ have declined 10.6%.

JAZZ’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.20%.

In the past 60 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share estimates have increased from 49 cents to 57 cents for 2026. Year to date, shares of DVAX have decreased 0.9%.

DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.

In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.40 to $7.00 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $10.84. Year to date, shares of KRYS have rallied 9.4%.

KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.

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