DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease
Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
Imfinzi reduced the risk of distant metastases and death from bladder cancer vs. neoadjuvant chemotherapy alone
Cancer cases in India estimated to reach 1.57 million in 2025
This collaboration aims to bridge modern scientific research with traditional Ayurvedic wisdom, fostering innovative solutions that support holistic well-being
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
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