Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors
Shots:
- The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) to treat previously treated adults with HER2+ (IHC 3+) unresectable or metastatic solid tumors, who have unsatisfactory alternative treatment options
- MAA was supported by 3 P-II (DESTINY-PanTumor02, DESTINY-CRC02 & DESTINY-Lung01) trials, where DESTINY-PanTumor02 (n=267, incl. 111 HER2+ pts) assessed Enhertu (5.4mg/kg) in solid tumors while DESTINY-CRC02 (n=122 incl. 64 HER2+) & DESTINY-Lung01 (n=181, incl. 17 HER2+) evaluated Enhertu (6.4 & 5.4mg/kg) in colorectal cancer & NSCLC, respectively
- Enhertu is being jointly developed & commercialized by Daiichi Sankyo & AstraZeneca, plus showed superior responses across a broad range of tumors in the trials
Ref: Daiichi Sankyo | Image: Daiichi Sankyo| Press Release
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