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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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AstraZeneca

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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  • The sBLA was submitted based on the results from the P-II (DESTINY-PanTumor02) trial evaluating the safety & efficacy of Enhertu (5.4mg/kg) in previously treated patients (n=267) with HER2-expressing tumors. The 1EP of the study was ORR & 2EPs were DoR, DCR, PFS, OS, safety, tolerability & PK
  • The results have depicted clinically meaningful and durable responses leading to clinically meaningful survival benefits in patients when treated with Enhertu. The US FDA assigned a PDUFA date for Q2’24
  • Moreover, additional supporting data from other trial incl. (DESTINY-Lung01) & (DESTINY-CRC02) were also submitted along with the sBLA. Enhertu, an HER2-directed ADC is jointly developed & commercialized by AstraZeneca & Daiichi Sankyo

Ref: AstraZeneca | Image: AstraZeneca

Related News:- AstraZeneca & Daiichi Sankyo Report Interim Analysis Results of Enhertu (trastuzumab deruxtecan) in the P-II Trial (DESTINY-PanTumor02) for HER2-Expressing Advanced Solid Tumors

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Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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