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EU panel backs Enhertu for early HER2-positive breast cancer

Fri, 18 Sep 2026 08:00:21 -0400

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Enhertu (trastuzumab deruxtecan) as an adjuvant treatment for adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted therapy.

The recommendation, based on results from the DESTINY-Breast05 phase 3 trial, will now be reviewed by the European Commission, which has the authority to grant marketing authorizations in the EU. Enhertu is jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/NYSE: AZN).

In the DESTINY-Breast05 trial, which enrolled 1,635 patients, Enhertu reduced the

EU panel backs Enhertu for early HER2-positive breast cancer

Fri, 18 Sep 2026 08:00:21 -0400

In the DESTINY-Breast05 trial, which enrolled 1,635 patients, Enhertu reduced the

Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer

Fri, 18 Sep 2026 08:00:00 -0400

Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1
Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting

TOKYO--(BUSINESS WIRE)-- Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment.

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate

Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer

Fri, 18 Sep 2026 08:00:00 -0400

Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1
Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate

Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer

Fri, 18 Sep 2026 08:00:00 -0400

Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1
Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate

Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer

Fri, 18 Sep 2026 08:00:00 -0400

Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1
Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate

Enhertu shows 14.3-month PFS in first-line lung cancer trial

Sun, 13 Sep 2026 21:45:26 -0400

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/NYSE: AZN) reported that their cancer drug Enhertu (trastuzumab deruxtecan) demonstrated a median progression-free survival (PFS) of 14.3 months as a first-line treatment in patients with HER2 mutant advanced non-small cell lung cancer (NSCLC), compared to 8.3 months for the current standard of care — pembrolizumab plus chemotherapy — in the phase 3 DESTINY-Lung04 trial.

The results, presented at the IASLC 2026 World Conference on Lung Cancer, showed Enhertu monotherapy reduced the risk of disease progression or death by 37% versus pembrolizumab plus chemotherapy (hazard ratio 0.63; p<0.0001). The objective response rate was 70.0% for

Enhertu shows 14.3-month PFS in first-line lung cancer trial

Sun, 13 Sep 2026 21:45:26 -0400

Enhertu® Demonstrated a Median Progression-Free Survival of 14.3 Months as First-Line Therapy in Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial

Sun, 13 Sep 2026 21:45:00 -0400

Represents a six-month improvement in median progression-free survival versus pembrolizumab plus chemotherapy
Daiichi Sankyo and AstraZeneca’s Enhertu is the first HER2 directed medicine to delay disease progression over standard of care in a phase 3 trial in this setting

TOKYO--(BUSINESS WIRE)-- Positive results from the DESTINY-Lung04 phase 3 trial showed Enhertu® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as a first-line treatment of patients with unresectable, locally advanced or metastatic HER2 mutant non-squamous non-small cell lung cancer

Enhertu® Demonstrated a Median Progression-Free Survival of 14.3 Months as First-Line Therapy in Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial

Sun, 13 Sep 2026 21:45:00 -0400

Represents a six-month improvement in median progression-free survival versus pembrolizumab plus chemotherapy
Daiichi Sankyo and AstraZeneca’s Enhertu is the first HER2 directed medicine to delay disease progression over standard of care in a phase 3 trial in this setting

Enhertu® Demonstrated a Median Progression-Free Survival of 14.3 Months as First-Line Therapy in Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial

Sun, 13 Sep 2026 21:45:00 -0400

Represents a six-month improvement in median progression-free survival versus pembrolizumab plus chemotherapy
Daiichi Sankyo and AstraZeneca’s Enhertu is the first HER2 directed medicine to delay disease progression over standard of care in a phase 3 trial in this setting

Enhertu® Demonstrated a Median Progression-Free Survival of 14.3 Months as First-Line Therapy in Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial

Sun, 13 Sep 2026 21:45:00 -0400

Represents a six-month improvement in median progression-free survival versus pembrolizumab plus chemotherapy
Daiichi Sankyo and AstraZeneca’s Enhertu is the first HER2 directed medicine to delay disease progression over standard of care in a phase 3 trial in this setting

New Daiichi Sankyo Data Underscore the Effect of Bempedoic Acid in the Real-World Management of Dyslipidemia and Cardiovascular risk