AstraZeneca and Daiichi Sankyo Reports sBLA Acceptance with Priority Review by the US FDA for Enhertu to Treat HER2-Expressing Solid Tumors
Shots:
- 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
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
