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EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -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) in combination with pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2 positive breast cancer in the European Union.

The recommendation, based on results from the DESTINY-Breast09 phase 3 trial, will now be reviewed by the European Commission, which has 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-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

EU panel backs Enhertu plus pertuzumab for HER2+ breast cancer

Fri, 24 Jul 2026 07:00:28 -0400

In the DESTINY-Breast09 trial, Enhertu combined with pertuzumab reduced the risk of

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

TOKYO--(BUSINESS WIRE)-- Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Fri, 24 Jul 2026 07:00:00 -0400

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years
If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer