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AstraZeneca, 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 review pathways.
- Trial investigators reported DESTINY-Breast09 showed a 44% risk reduction versus first-line therapy, with median PFS of 40.7 months and an 87% objective response rate among 1,157 patients.
- Safety data show ENHERTU 5.4 mg/kg with pertuzumab carries boxed warnings for interstitial lung disease /pneumonitis and embryo-fetal toxicity, with ILD in 12% of patients and fatal outcomes 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 supporting U.S. patients prescribed ENHERTU.
- Project Orbis is coordinating concurrent reviews of ENHERTU in Switzerland and Japan, with continued approval contingent on confirmatory trial requirements, amid the Daiichi Sankyo and AstraZeneca collaboration.
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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.
·United Kingdom
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MedPage TodayReposted by 
Anti-Aging, Acupuncture and Health News
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...
·New York, United States
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The Bakersfield Californian+2 Reposted by 2 other sources
ENHERTU® Plus Pertuzumab Approved in the U.S. as First New Treatment in More Than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer
TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Dec 15, 2025-
·Bakersfield, United States
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Leaning Left1Leaning Right1Center7Last UpdatedBias Distribution78% Center
Bias Distribution
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78% Center
11%
C 78%
11%
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