AstraZeneca and Daiichi Sankyo’s Enhertu Receives the US FDA’s Accelerated Approval to Treat Metastatic HER2-Positive Solid Tumors
Shots:
- The approval was supported by 3 P-II studies assessing the safety & efficacy of Enhertu incl. DESTINY-PanTumor02 (5.4mg/kg) for HER2-expressing tumors, DESTINY-Lung01 (5.4mg/kg or 6.4mg/kg) for HER2m or HER2-overexpressing inoperable/metastatic non-squamous NSCLC & DESTINY-CRC02 (5.4mg/kg or 6.4mg/kg) for locally advanced, unresectable or metastatic HER2+ colorectal cancer
- A confirmed ORR of 51.4%, 52.9% & 46.9% while mDoR of 19.4mos., 6.9mos. & 5.5mos. was observed in the DESTINY-PanTumor02, DESTINY-Lung01 & DESTINY-CRC02 studies, respectively
- On the basis of these results, Enhertu has been added to the NCCN guidelines for the treatment of various metastatic tumors
Ref: AstraZeneca | Image: AstraZeneca
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
