Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have announced the acceptance of their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) in the U.S. The application targets the treatment of adult patients battling locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), who have undergone prior systemic therapy.

Datopotamab deruxtecan, a pioneering TROP2 directed DXd antibody drug conjugate (ADC), is the result of collaborative efforts between Daiichi Sankyo and AstraZeneca.

The Prescription Drug User Fee Act (PDUFA) date, set for December 20, 2024, marks the U.S. Food and Drug Administration's (FDA) anticipated decision on regulatory approval.

The BLA draws upon data from the pivotal TROPION-Lung01 phase 3 trial, presented at the European Society for Medical Oncology (ESMO23) 2023 Congress. This trial showcased datopotamab deruxtecan's significant advancement in progression-free survival (PFS) over docetaxel, the prevailing standard of care, among patients with locally advanced or metastatic NSCLC who had previously received at least one line of therapy. While interim results for overall survival (OS) showed a favorable trend in favor of datopotamab deruxtecan, statistical significance was not reached at the time of data cut-off. Encouragingly, patients with nonsquamous NSCLC exhibited clinically meaningful PFS benefits and a favorable OS trend. Safety profiles remained consistent with those observed in other ongoing trials, with no novel safety concerns identified.

Dr. Ken Takeshita, Global Head of R&D at Daiichi Sankyo, expressed optimism, stating, "Today's news marks a significant stride towards establishing new treatment standards for non-small cell lung cancer patients." He added, "We are committed to working closely with the FDA to potentially bring datopotamab deruxtecan to fruition as the premier TROP2 directed antibody drug conjugate for nonsquamous non-small cell lung cancer patients post prior systemic therapy."

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, echoed these sentiments, highlighting datopotamab deruxtecan's potential to provide a viable and tolerable alternative to traditional chemotherapy for patients with previously treated advanced nonsquamous non-small cell lung cancer.

With ongoing regulatory discussions globally and a parallel submission underway in the U.S. for breast cancer, Daiichi Sankyo and AstraZeneca are committed to advancing the accessibility of datopotamab deruxtecan across various cancer indications, underscoring their dedication to improving patient outcomes in oncology