The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults, as well as unresectable or metastatic HR+, HER2- breast cancer in adults.
These filings are supported by data from two distinct late-stage studies, which had primary endpoints of progression-free survival (PFS) and overall survival (OS). Key secondary endpoints included objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and safety.- Flcube.com
