Daiichi Sankyo and AstraZeneca's Datroway Shows Promise in Competitive ADC Market

Daiichi Sankyo and AstraZeneca's antibody-drug conjugate (ADC) Datroway is off to a "smooth market launch," according to Daiichi CEO Hiroyuki Okuzawa. The TROP2-directed treatment, which follows in the footsteps of the companies' successful ADC Enhertu, has generated 1.4 billion Japanese yen ($10 million) in sales through March 2025.

Initial Success and Expansion Plans

Datroway received approval in Japan in December 2024 and in the U.S. in January 2025 for unresectable or metastatic, hormone receptor (HR) positive, HER2-negative breast cancer in patients who have tried prior endocrine-based therapy and chemotherapy. The companies are now eyeing a potentially larger market opportunity in non-small cell lung cancer (NSCLC).

An FDA decision for Datroway's use in EGFR nonmutated NSCLC patients who have received prior systemic therapies is expected by July 12, 2025. This submission follows a strategic pivot after mixed results in the phase 3 Tropion-Lung01 study led to the withdrawal of an earlier filing for second-line nonsquamous NSCLC.

Financial Projections and Market Competition

Daiichi is projecting Datroway sales to reach 4.7 billion Japanese yen ($33 million) in the new fiscal year. This forecast comes as the drug faces competition from Gilead Sciences' Trodelvy, another TROP2-targeted ADC that generated $1.3 billion in sales last year.

AstraZeneca's substantial investment in Datroway – a $1 billion upfront payment with up to $5 billion in potential milestones – underscores the high expectations for the drug. AstraZeneca has projected peak sales of Datroway at $5 billion.

Enhertu's Continued Success

While Datroway establishes its market presence, Enhertu continues to be a powerhouse for Daiichi Sankyo and AstraZeneca. The drug logged sales of $3.7 billion in Daiichi's 2024 fiscal year, with projections reaching 662 billion Japanese yen ($4.6 billion) for the current fiscal year.

These developments contribute to Daiichi Sankyo's overall growth, with the company reporting revenue of 1.886 trillion Japanese yen ($13.2 billion) for the 2024 fiscal year, an 18% increase from the previous year. Looking ahead, Daiichi expects a more modest 6% growth to 2 trillion Japanese yen ($14 billion) in the current fiscal year.