AstraZeneca, Daiichi Will Seek Approval Following ADC Trial Success In Advanced Breast Cancer
AstraZeneca and Daiichi said their pivotal Phase II DESTINY-Breast01 trial assessing the HER2-targeting antibody drug conjugate trastuzumab deruxtecan met its primary endpoint, supporting global regulatory submission plans starting in this year’s second half.
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The company expects to file an NDA for tucatinib in the first quarter after a pivotal trial showed a significant improvement in PFS and OS for patients with advanced or metastatic HER2-positive breast cancer, including those with brain metastases.
Keeping Track: A Novel Approval For Fluorodopa F 18, A Tentative Approval For Vumerity, And A Missed Goal Date For Zilretta
The latest drug development news and highlights from our US FDA Performance Tracker.