Daiichi Sankyo US

PMDA approves ENHERTU for HER2-low breast cancer in Japan

5 min

PMDA approved ENHERTU for unresectable or metastatic HER2-low breast cancer in Japan, marking a new regulatory catalyst for Daiichi Sankyo and AstraZeneca. The decision expands the drug’s labeled use in a major market and adds another milestone for investors tracking ENHERTU.

EMA backs datopotamab deruxtecan, but lung cancer access remains unclear

EMA · lung cancer · 9 min

EMA recommended datopotamab deruxtecan in Europe, but the supported EU approval in the evidence base is for HR-positive, HER2-negative breast cancer rather than lung cancer. In the U.S., DATROWAY has accelerated approval for EGFR-mutated NSCLC, making this a key catalyst-tracking update for BD teams and investors.

EMA backs datopotamab deruxtecan for advanced lung cancer

EMA · lung cancer · 10 min

EMA action on datopotamab deruxtecan adds a key catalyst for lung cancer tracking, even as the program’s regulatory path differs by region. For BD teams, investors, and analysts, the story now centers on approval status, label scope, and the next clinical and filing milestones.

AstraZeneca and Daiichi Sankyo datopotamab deruxtecan hits lung cancer endpoint

oncology · 8 min

AstraZeneca and Daiichi Sankyo datopotamab deruxtecan met the dual primary endpoint of progression-free survival in TROPION-Lung01, strengthening the program’s clinical case in advanced NSCLC. The readout matters for investors and BD teams because it arrives alongside an FDA-labeled EGFR-mutated NSCLC indication and a mixed breast cancer survival backdrop.

AstraZeneca and Daiichi's Datroway (Dato-DXd) Approved for Triple-Negative Breast Cancer: Implications for Pharma

FDA · breast cancer · 5 min

The FDA approved AstraZeneca and Daiichi Sankyo's Datroway (Dato-DXd) as a first-line treatment for triple-negative breast cancer on May 1, 2026. This article provides key takeaways, regulatory details, and strategic implications for pharma decision-makers.

Merck's ADC Success: Insights from Global Trial Results

FDA · oncology · 8 min

This article delves into Merck's successful antibody-drug conjugates (ADCs) and their global trial results, highlighting key insights for investors and BD teams.

ESMO 2025 Preview: Astra and Daiichi vs. Gilead

oncology · 3 min

As ESMO 2025 approaches, Astra and Daiichi are positioning themselves against Gilead. This article analyzes the implications for investors and pharma teams.

FDA Approval for Datroway: Implications for Breast Cancer Treatment

FDA · breast cancer · 2 min

The FDA has granted approval for Datroway, a significant development for breast cancer treatment by Daiichi Sankyo and AstraZeneca. This article explores the implications for investors and pharma teams.

AstraZeneca and Daiichi Secure FDA Approval for Datroway in TNBC

FDA · TNBC · 3 min

AstraZeneca and Daiichi have gained FDA approval for Datroway as a first-line treatment for TNBC, surpassing Gilead. This article explores the implications for the pharmaceutical landscape.

Fierce Pharma Asia: Major Developments in Oncology and Workforce Changes

oncology · 2 min

This article covers significant developments in the pharmaceutical sector, including BMS's $15B deal with Hengrui, Takeda's workforce reductions, and Daiichi's oncology initiatives.