US EditionAstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment
FDA approval follows DESTINY-Breast09 trial showing 44% reduced progression risk and median progression-free survival of 40.7 months with Enhertu plus pertuzumab.
- On Monday the U.S. Food and Drug Administration approved ENHERTU with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.
- Presented earlier this year, DESTINY‑Breast09 showed T‑DXd plus pertuzumab reduced progression risk by 44% and achieved a median PFS of 40.7 months versus 26.9 months with THP.
- In the DESTINY‑Breast09 safety analysis, the confirmed objective response rate was 87% with 15% complete responses, while interstitial lung disease occurred in about 12% and serious adverse reactions in 27% of patients.
- The approval could reshape prescribing by introducing the first new first‑line option for HER2‑positive metastatic breast cancer in more than a decade, affecting approximately 10,000 U.S. first‑line patients and triggering a $150 million milestone payment to Daiichi Sankyo amid ENHERTU sales growth this year.
- FDA also cleared companion diagnostics for HER2 status, the ENHERTU label requires Boxed WARNINGS for ILD/pneumonitis and embryo‑fetal toxicity with monitoring, and Project Orbis reviews plus confirmatory trials mean continued approval is conditional while OS data are immature.
24 Articles
24 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...
Coverage Details
Bias Distribution
- 80% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
