AZN, Daiichi's Enhertu sBLA Gets FDA Priority Review for Breast Cancer

AstraZeneca AZN and Japan-based partner Daiichi Sankyo announced that the FDA has accepted a supplemental biologics license application (sBLA), which seeks label expansion for their blockbuster antibody-drug conjugate (ADC), Enhertu, in breast cancer.

The sBLA seeks approval for Enhertu, combined with Roche’s RHHBY cancer drug Perjeta (pertuzumab), for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

The filing has been granted priority review by the FDA, bringing down the review period by four months. A final decision is expected in the first quarter of 2026.

AZN, Daiichi Boast Enhertu Supremacy

The sBLA filing is supported by data from the phase III DESTINY-Breast09 study, which evaluated the Enhertu-Perjeta combo against the current standard of care — taxane chemotherapy combined with Roche’s cancer drugs Herceptin and Perjeta (“THP”). This study achieved its primary endpoint of progression-free survival (PFS), as treatment with Enhertu plus Perjeta reduced the risk of disease progression by 44% compared with THP. Median PFS reached nearly 41 months versus about 27 months with THP.

The Enhertu-Perjeta regimen also demonstrated a higher objective response rate (ORR) of 85.1% (including 58 complete responses) compared to 78.6% (including 33 complete responses) for THP.

AstraZeneca noted that these results mark the first major advance in first-line HER2-positive metastatic breast cancer in over a decade. If approved, the combination could become the new standard of care.

Enhertu is already approved for the second-line treatment of patients with HER2-positive breast cancer in more than 85 countries, including the United States. It also holds approvals in HER2-targeted indications for lung and gastric cancers.

AZN Stock Performance

Year to date, AstraZeneca’s shares have gained 15% compared with the industry’s 4% growth.

AZN’s Daiichi Deal for Enhertu & Other ADC Drugs

Enhertu is the first ADC developed under AstraZeneca’s collaboration with Daiichi Sankyo, followed by Datroway, which received its first FDA approval at the onset of this year for breast cancer and, more recently, for lung cancer. Per the terms of the partnership, both companies are jointly responsible for developing and marketing the drugs worldwide, except in Japan, where Daiichi maintains exclusive rights for both. Daiichi is also responsible for the manufacturing and supply of both Enhertu and Datroway.

Both companies are pursuing broad development programs for Enhertu and Datroway, testing them as monotherapies and in combinations across multiple tumor types.

Per AstraZeneca, both Enhertu and Datroway are part of a select group of therapies that could achieve peak annual sales of at least $5 billion. These medicines are central to the company’s ambitious growth strategy to achieve $80 billion in annual revenues by 2030.

AZN’s Competition in the Evolving ADC Space

ADCs are being considered disruptive innovations in the pharmaceutical industry, as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.

Daiichi Sankyo has several ADCs in clinical development across multiple types of cancer. Like AstraZeneca, Daiichi also has a similar partnership with Merck MRK. This MRK deal, which was signed in 2023, involves the development of three investigational ADCs — patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan — across multiple solid tumor indications. Per Merck, this deal holds multi-billion-dollar worldwide commercial revenue potential for each company approaching the mid-2030s.

Pfizer PFE also tapped into the lucrative ADC space with the acquisition of Seagen for $43 billion in late 2023. Following this acquisition, PFE added four ADCs to its portfolio — Adcetris, Padcev, Tukysa and Tivdak — all approved across various types of solid tumors and hematologic malignancies. These products contributed meaningfully to Pfizer’s revenues in the first half of 2025.

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AstraZeneca currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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