Daiichi Sankyo and AstraZeneca’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the U.S. FDA for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have previously received systemic therapy.
As a specifically constructed TROP2-targeted DXd antibody drug conjugate (ADC), datopotamab deruxtecan shows promise in addressing NSCLC, and the FDA is expected to make a regulatory decision by December 20, 2024.
The BLA is based on results from the pivotal TROPION-Lung01 phase 3 trial, which demonstrated datopotamab deruxtecan’s statistically significant improvement in progression-free survival (PFS) compared to docetaxel, the current standard of care, in patients who had previously undergone at least one line of therapy. The interim results for the dual primary endpoint of overall survival (OS) were numerically in favor of datopotamab deruxtecan but did not reach statistical significance at the time of data cut-off.
Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, emphasized the significance of this development as they aim to establish a new standard of care for NSCLC patients. They are encouraged by the FDA’s acceptance of the BLA and are keen to make datopotamab deruxtecan the first TROP2-directed ADC for this patient group.
Susan Galbraith of AstraZeneca also noted the potential of datopotamab deruxtecan to provide an effective alternative to traditional chemotherapy for those with advanced nonsquamous NSCLC.
Simultaneously, a parallel BLA is pending for the treatment of metastatic hormone receptor-positive, HER2-negative breast cancer, and additional global submissions are underway for both lung and breast cancer indications.
TROPION-Lung01 is a global, randomized, multicenter, open-label phase 3 trial exploring the efficacy and safety of datopotamab deruxtecan versus docetaxel in patients with NSCLC, marking a crucial stride toward innovative lung cancer treatments with the potential to be made available swiftly to patients worldwide.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
