Shots:
- The US FDA has accepted sBLA & granted priority review to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jan 23, 2026)
- sBLA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157)
- Trial showed improved PFS by 44% (mPFS: 40.7 vs 26.9mos.) & consistent PFS benefit across subgroups, plus cORR was 85.1% vs 78.6% (58 CRs & 268 PRs vs 33 CRs & 271 PRs), mDoR was 39.2 vs 26.4mos.; data was presented at ASCO 2025
Ref: Daiichi Sankyo | Image: AstraZeneca & Daiichi Sankyo | Press Release
Related News:- AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer
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