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Trastuzumab deruxtecan received its tenth indication in China on October 20, for adults with unresectable or metastatic solid tumors expressing HER2 at IHC 3+ who have received prior treatment or have no satisfactory alternative treatment options. It is the first HER2-targeted ADC approved for a tumor-agnostic indication in China.
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- mp.weixin.qq.comTrastuzumab Deruxtecan Wins Tumor-Agnostic Approval in China, Its Tenth Indication
Trastuzumab deruxtecan received its tenth indication in China on October 20, for adults with unresectable or metastatic solid tumors expressing HER2 at IHC 3+ who have received prior treatment or have no satisfactory alternative treatment options. It is the first HER2-targeted ADC approved for a tumor-agnostic indication in China.
- mp.weixin.qq.comPickTrastuzumab Deruxtecan Receives Conditional Tumor-Agnostic HER2 Approval in China
Trastuzumab deruxtecan (Enhertu) has received conditional approval in China as monotherapy for adults with unresectable or metastatic solid tumors expressing HER2 at IHC 3+ who have received prior treatment or have no satisfactory alternative options. The approval is based on four phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and DESTINY-PanTumor03, with full approval contingent on clinical benefit demonstrated in confirmatory trials.
- mp.weixin.qq.comPickTrastuzumab Deruxtecan Gains Conditional Tumor-Agnostic HER2-Positive Approval in China
Daiichi Sankyo's trastuzumab deruxtecan (Enhertu) has been approved in China for adult patients with unresectable or metastatic solid tumors expressing HER2 IHC 3+ who have received prior treatment or have no satisfactory alternative options. The approval, granted conditionally by the NMPA, covers a tumor-agnostic indication.
- mp.weixin.qq.comDaiichi Sankyo and AstraZeneca's Trastuzumab Deruxtecan Wins Tumor-Agnostic Indication in China
On October 22, Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan received approval in China for a new tumor-agnostic indication: adults with unresectable or metastatic HER2 IHC 3+ solid tumors who have received prior treatment or have no satisfactory alternative options. The CDE had granted the indication priority review. Since its first approval in December 2019, the drug has expanded across breast cancer, gastric cancer and non-small cell lung cancer, among other tumor types.
- clinicaltrials.govBL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy
A newly registered phase 3 trial (NCT07869836) will randomize 520 participants with HER2-expressing metastatic urothelial cancer progressing on or after anti-PD-(L)1-based therapy to BL-M07D1 (trastuzumab brengitecan, T-bren) at one of two dose levels versus gemcitabine plus platinum-based chemotherapy (cisplatin or carboplatin). Sponsored by SystImmune, it is recruiting with a planned start in September 2026 and will evaluate efficacy and safety.
- biorxiv.orgPickTrastuzumab deruxtecan kills skin and uveal melanoma in vivo by HER2-independent payload release
Trastuzumab deruxtecan (T-DXd) inhibited all subcutaneous melanoma PDXs and outperformed trastuzumab emtansine (T-DM1), which had limited activity, while liver models were less sensitive. Parental and ERBB2-knockout xenografts responded similarly at first, though knockout tumors regrew earlier, and melanoma cells resisted both ADCs in vitro with little trastuzumab uptake. Tumor-derived cathepsin L found outside melanoma cells suggests payload release can occur extracellularly, independent of HER2.
- mp.weixin.qq.comPickFDA Approves Pfizer's TUKYSA Plus Trastuzumab and Pertuzumab for First-Line HER2+ Breast Cancer Maintenance
The FDA approved Pfizer's TUKYSA (tucatinib) combined with trastuzumab and pertuzumab as maintenance therapy after induction treatment for adults with unresectable locally advanced or metastatic HER2-positive breast cancer. The approval extends TUKYSA into the first-line setting and offers a chemotherapy-free maintenance option. According to Pfizer, the regimen reduced the risk of death by 35.9% compared with trastuzumab alone.
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Heat now 53·Peak in the comparable set 131 (Oct 24 01:00)·Change over 24h in the comparable set -44%·Participants now 18
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