AstraZeneca and Daiichi Sankyo’s Enhertu Receives the US FDA’s Accelerated Approval to Treat Metastatic HER2-Positive Solid Tumors

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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

Related News:- AstraZeneca and Daiichi Sankyo Reports sBLA Acceptance with Priority Review by the US FDA for Enhertu to Treat HER2-Expressing Solid Tumors

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