The Babak Lab shared a post on LinkedIn:
“FDA approves Datroway for metastatic triple-negative breast cancer.
The FDA has approved datopotamab deruxtecan-dlnk (Datroway, Dato-DXd) for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
Key Insights:
- The approval is based on the phase 3 TROPION-Breast02 trial.
- Datroway reduced the risk of disease progression or death compared with investigator’s choice chemotherapy.
- Median PFS was 10.8 months with Datroway against 5.6 months with chemotherapy.
- Median OS was 23.7 months against 18.7 months, respectively.
- Confirmed ORR was 64% with Datroway compared with 30% with chemotherapy.
- Key warnings include interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis/oral mucositis, and embryo-fetal toxicity.
Conclusion:
- This approval adds another TROP2-directed ADC option for patients with unresectable or metastatic TNBC.
Image generated using Sora by OpenAI.”
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