US EditionAstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment
ENHERTU with pertuzumab reduces disease progression risk by 44% and extends median progression-free survival beyond three years, based on DESTINY-Breast09 trial data.
- Following late‑breaking ASCO25 data, the FDA approved AstraZeneca and Daiichi Sankyo's ENHERTU with pertuzumab as first-line treatment for unresectable or metastatic HER2-positive breast cancer, using expedited pathways.
- DESTINY-Breast09 phase 3 data showed a 44% reduction in risk of progression or death versus THP, median progression-free survival of 40.7 months, and an 87% confirmed objective response rate among 1,157 patients.
- Clinical trial safety findings include boxed warnings for interstitial lung disease /pneumonitis and embryo-fetal toxicity, with ILD in 12% and fatal ILD/pneumonitis in 0.5%.
- Clinicians could adopt the regimen as a new first-line standard, while AstraZeneca will pay Daiichi Sankyo a $150 million milestone and both commit to U.S. patient access and support programs.
- Project Orbis is coordinating concurrent reviews in Switzerland and Japan, while continued approval may require confirmatory trial verification; ENHERTU is key to Daiichi Sankyo and AstraZeneca collaboration.
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23 Articles
AstraZeneca, Daiichi Sankyo ADC Enhertu Moves Up to First-Line Use in Breast Cancer
FDA approval for Enhertu as a first-line breast cancer treatment is important because many patients with HER2-positive cancer do not live long enough to receive a second line of therapy. In Enhertu’s pivotal study in this setting, the HER2-targeting ADC helped patients live more than three years without disease progression or death. The post AstraZeneca, Daiichi Sankyo ADC Enhertu Moves Up to First-Line Use in Breast Cancer appeared first on Med…
AstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's Enhertu in combination with Roche's drug, Perjeta, for the first-line treatment of patients with a type of breast cancer, the regulator said on Monday.
MedPage Today
Anti-Aging, Acupuncture and Health NewsBlockbuster Drug Lands First-Line Indication for HER2-Positive Breast Cancer
(MedPage Today) -- The FDA approved trastuzumab deruxtecan (T-DXd; Enhertu) in combination with pertuzumab (Perjeta) for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Approval was based on results...
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