Daiichi Sankyo Kicks Off 2025 with FDA Approval for Datroway, Looks to Rebound After Mixed 2024

Japanese pharmaceutical giant Daiichi Sankyo is starting 2025 on a high note with the FDA approval of its new breast cancer drug Datroway (datopotamab deruxtecan), despite facing setbacks in the previous year. The company is positioning itself for a potentially transformative year ahead, with multiple clinical trial readouts expected across its antibody-drug conjugate (ADC) portfolio.

Datroway Approval Marks Positive Start to 2025

Daiichi Sankyo and partner AstraZeneca secured FDA approval for Datroway (Dato-DXd) for the treatment of patients with unresectable or metastatic breast cancer who are HR-positive and HER2-negative. This marks the first approved indication for the drug, which is part of the companies' growing ADC pipeline.

Ken Keller, CEO of Daiichi Sankyo's U.S. subsidiary and head of the Global Oncology Business, expressed optimism about the approval and the year ahead. "I've never been able to say, 'We've got eight top line readouts for registration trials' at any company I've been at," Keller stated. "So I think it could be a really special year."

Navigating Challenges and Learning from 2024

While celebrating the recent approval, Daiichi Sankyo acknowledges that 2024 presented challenges. The company received a complete response letter from the FDA for patritumab deruxtecan (HER3-DXd) and withdrew a regulatory application for Dato-DXd in non-small cell lung cancer (NSCLC).

Keller reflected on these setbacks, stating, "It was not a perfect year." However, the company views these experiences as opportunities for growth and refinement of their development strategies.

In response to the Dato-DXd withdrawal, Daiichi Sankyo has refiled the application for a more targeted population of patients with EGFR-mutated NSCLC. The FDA has granted priority review for this indication, with a decision expected in July 2025.

Expanding ADC Portfolio and Clinical Trial Pipeline

Daiichi Sankyo is leveraging its expertise in ADC technology to drive future growth. The company anticipates top-line readouts for eight registrational trials across its ADC portfolio in 2025, including:

• Five new indications for Enhertu
• Two indications for Dato-DXd (EGFR-mutated NSCLC and triple-negative breast cancer)
• A registrational trial for ifinatamab deruxtecan (I-DXd) in small cell lung cancer

The company is also exploring innovative approaches to ADC development, including bispecific ADCs that carry two different payloads to target cancer from multiple angles.

Keller emphasized the rapid evolution of ADC science, stating, "It's just the beginning of the science. Unfortunately, cancer is smart. It evolves." This perspective underscores Daiichi Sankyo's commitment to continuous innovation in the face of emerging resistance mechanisms.