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AstraZeneca's Enhertu Wins EU Nod for HER2-Positive Solid Tumors (Revised)
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Key Takeaways
AstraZeneca's Enhertu secured its sixth EU indication for previously treated HER2-positive solid tumors.
AZN will pay Daiichi Sankyo a $25 million milestone payment after the latest EU approval for Enhertu.
Datroway earned a positive CHMP opinion for first-line TNBC based on phase III survival benefits.
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo announced that the European Commission (EC) has approved their blockbuster antibody-drug conjugate (ADC), Enhertu, as a monotherapy for previously treated HER2-positive solid tumors. The approval marks Enhertu's sixth indication in the European Union (EU).
Separately, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of another ADC, Datroway (datopotamab deruxtecan),for expanded use in breast cancer.
AstraZeneca and Daiichi entered a global collaboration in March 2019 to jointly develop and commercialize Enhertu, followed by an expansion of the partnership in July 2020 to include Datroway. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. Daiichi also records sales of Enhertu in the United States.
Year to date, AZN’s shares have risen 2.5% compared with the industry’s 5.2% growth.
Image Source: Zacks Investment Research
Enhertu Becomes AZN's First Tumor-Agnostic ADC in EU
Enhertu won the EU nod as a monotherapy for previously treated adults with unresectable or metastatic HER2-positive solid tumors. The approval was expected, as the EMA's CHMP issued a positive opinion in May, recommending approval for this indication.
The EC approval is based on positive data from the phase II DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 studies. Data from these studies have shown that treatment with Enhertu led to clinically meaningful responses across a broad range of tumors.
Enhertu is approved in several HER2-expressing indications as well as HER2-mutated indications in breast, lung and gastric cancers.
The newest approval establishes Enhertu as the first HER2-targeted therapy and ADC to receive a tumor-agnostic indication in the European Union. The drug has already received a tumor-agnostic indication in the United States and other countries.
Following the EU approval, AstraZeneca is entitled to pay $25 million as a milestone payment to Daiichi Sankyo under their collaboration agreement.
CHMP Recommends AZN’s Datroway for First-Line TNBC
The CHMP of EMA recommended approval of AZN and Daiichi Sankyo’s Datroway as the first-line monotherapy for adult patients with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy.
If approved, Datroway would be the first TROP2-directed ADC in the EU for this patient population.
The CHMP opinion from the EMA was supported by data from the phase III TROPION-Breast02 study. The study met its primary endpoints by demonstrating statistically significant and clinically meaningful improvements in overall survival and by reducing the risk of disease progression or death versus chemotherapy when used as first-line treatment. Datroway also delivered a higher objective response rate and longer duration of response than chemotherapy.
Datroway was approved for the same first-line TNBC indication in the United States in May and regulatory applications are under review in several additional markets, including China and Japan.
More on AZN’s Datroway
Beyond the TNBC setting, AZN already markets Datroway globally for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer following prior endocrine therapy and chemotherapy.
Other than in breast cancer, Datroway is also approved in the United States under accelerated approval for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have progressed after EGFR-directed therapy and platinum-based chemotherapy.
Datroway is being evaluated as monotherapy and in combination treatments in various settings across several late-stage studies globally across multiple cancers, including lung, breast and urothelial cancers.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 88 cents to 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 11% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
Over the past 60 days, loss per share estimates for Amarin Corporation have narrowed from $15.20 to 65 cents for 2026. Over the same period estimates for loss per share have also narrowed from $13.00 to 51 cents for 2027. AMRN shares have risen 14.1% year to date.
Amarin Corporation’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 126.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
(We are reissuing this article to correct a mistake. The original article, issued on June 29, 2026, should no longer be relied upon.)
View the Zacks #1 Rank List
Image: Bigstock
AstraZeneca's Enhertu Wins EU Nod for HER2-Positive Solid Tumors (Revised)
Key Takeaways
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo announced that the European Commission (EC) has approved their blockbuster antibody-drug conjugate (ADC), Enhertu, as a monotherapy for previously treated HER2-positive solid tumors. The approval marks Enhertu's sixth indication in the European Union (EU).
Separately, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of another ADC, Datroway (datopotamab deruxtecan),for expanded use in breast cancer.
AstraZeneca and Daiichi entered a global collaboration in March 2019 to jointly develop and commercialize Enhertu, followed by an expansion of the partnership in July 2020 to include Datroway. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. Daiichi also records sales of Enhertu in the United States.
Year to date, AZN’s shares have risen 2.5% compared with the industry’s 5.2% growth.
Image Source: Zacks Investment Research
Enhertu Becomes AZN's First Tumor-Agnostic ADC in EU
Enhertu won the EU nod as a monotherapy for previously treated adults with unresectable or metastatic HER2-positive solid tumors. The approval was expected, as the EMA's CHMP issued a positive opinion in May, recommending approval for this indication.
The EC approval is based on positive data from the phase II DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 studies. Data from these studies have shown that treatment with Enhertu led to clinically meaningful responses across a broad range of tumors.
Enhertu is approved in several HER2-expressing indications as well as HER2-mutated indications in breast, lung and gastric cancers.
The newest approval establishes Enhertu as the first HER2-targeted therapy and ADC to receive a tumor-agnostic indication in the European Union. The drug has already received a tumor-agnostic indication in the United States and other countries.
Following the EU approval, AstraZeneca is entitled to pay $25 million as a milestone payment to Daiichi Sankyo under their collaboration agreement.
CHMP Recommends AZN’s Datroway for First-Line TNBC
The CHMP of EMA recommended approval of AZN and Daiichi Sankyo’s Datroway as the first-line monotherapy for adult patients with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy.
If approved, Datroway would be the first TROP2-directed ADC in the EU for this patient population.
The CHMP opinion from the EMA was supported by data from the phase III TROPION-Breast02 study. The study met its primary endpoints by demonstrating statistically significant and clinically meaningful improvements in overall survival and by reducing the risk of disease progression or death versus chemotherapy when used as first-line treatment. Datroway also delivered a higher objective response rate and longer duration of response than chemotherapy.
Datroway was approved for the same first-line TNBC indication in the United States in May and regulatory applications are under review in several additional markets, including China and Japan.
More on AZN’s Datroway
Beyond the TNBC setting, AZN already markets Datroway globally for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer following prior endocrine therapy and chemotherapy.
Other than in breast cancer, Datroway is also approved in the United States under accelerated approval for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have progressed after EGFR-directed therapy and platinum-based chemotherapy.
Datroway is being evaluated as monotherapy and in combination treatments in various settings across several late-stage studies globally across multiple cancers, including lung, breast and urothelial cancers.
AZN’s Zacks Rank & Stocks to Consider
AZN currently carries a Zacks Rank #3 (Hold).
Some other top-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Amarin Corporation (AMRN - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 88 cents to 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 11% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
Over the past 60 days, loss per share estimates for Amarin Corporation have narrowed from $15.20 to 65 cents for 2026. Over the same period estimates for loss per share have also narrowed from $13.00 to 51 cents for 2027. AMRN shares have risen 14.1% year to date.
Amarin Corporation’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 126.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
(We are reissuing this article to correct a mistake. The original article, issued on June 29, 2026, should no longer be relied upon.)