AZN, Daiichi's Datroway Wins FDA Nod for Expanded Use in Breast Cancer

AstraZeneca AZN and its Japan-based partner Daiichi Sankyo announced that the FDA has approved their blockbuster antibody-drug conjugate (ADC), Datroway (datopotamab deruxtecan), for expanded use in breast cancer.

The regulatory body has now approved Datroway for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor therapy.

Per management, Datroway has the potential to become the new standard of care in this setting.

AZN already markets Datroway globally for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer following prior endocrine therapy and chemotherapy.

AZN’s Price Performance

Year to date, shares of AstraZeneca have risen 1.8% against the industry’s decline of 0.3%.Zacks Investment Research

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The latest FDA nod was based on data from the phase III TROPION-Breast02 study, which demonstrated statistically significant and clinically meaningful improvements in overall survival and reduced the risk of disease progression or death versus chemotherapy when used as first-line treatment in the given patient population.

Treatment with Datroway also led to a higher objective response rate and duration of response than chemotherapy.

Based on data from the TROPION-Breast02 study, Datroway has been added to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 preferred first-line treatment option for patients with metastatic TNBC who are not eligible for immunotherapy.

More on AZN/Daiichi’s Datroway Development Program

Besides breast cancer, Datroway is also approved in the United States under accelerated approval for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have progressed after EGFR-directed therapy and platinum-based chemotherapy.

Continued approval for this indication in the United States may depend on confirmation and further demonstration of clinical benefit in a confirmatory study.

Datroway, both as monotherapy and in combination with other cancer treatments, is being evaluated in several late-stage studies globally across multiple cancers, including lung, breast and urothelial cancer.

AstraZeneca and Daiichi Sankyo have been jointly developing and commercializing Datroway under their global collaboration since 2020, with Daiichi Sankyo responsible for manufacturing and supply. Daiichi also maintains exclusive rights for Datroway in Japan.

AZN Zacks Rank & Stocks to Consider

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

Story Continues

Some better-ranked stocks in the biotech sector are Immunocore IMCR, Design Therapeutics DSGN and Jasper Therapeutics JSPR, each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents to earnings of 11 cents. IMCR stock has lost 16.9% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.

Over the past 60 days, 2026 loss per share estimates for Design Therapeutics have narrowed from $1.46 to $1.36, while the same for 2027 have narrowed from $1.77 to $1.70. DSGN stock has rallied 16.9% year to date.

Design Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 13.48%.

Over the past 60 days, 2026 loss per share estimates for Jasper Therapeutics have narrowed from $3.25 to $1.64, while the same for 2027 have narrowed from $2.19 to $1.09. JSPR stock has plunged 50.6% year to date.

Jasper Therapeutics’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 5.00%.

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