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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Novel antibody-drug conjugate receives approval in Japan for second-line breast cancer, providing another push to Japanese firm’s strategic plan to build up its oncology operations.
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.