Additional BLA under review in USA for datopotamab deruxtecan

An additional Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the US Food and Drug Administration.

Under development by UK pharma major AstraZeneca (LSE: AZN) and Japanese partner Daiichi Sankyo’s (TYO: 4568), the new Dato-DXd BLA is intended for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease. The deal between the companies provides for the Japanese firm to earn nearly $7 billion from AstraZeneca.

The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is scheduled during the first quarter of 2025.