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AZN, Daiichi's Enhertu Gets Positive CHMP Opinion for Solid Tumors
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Key Takeaways
Enhertu won CHMP backing for HER2-positive solid tumors after prior treatment in the EU.
AZN said Enhertu could become the EU's first HER2-targeted tumor-agnostic ADC therapy.
AZN's camizestrant combo won CHMP nod for first-line advanced ER-positive breast cancer.
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending the EU approval of their blockbuster antibody-drug conjugate (ADC), Enhertu, for certain solid tumours.
The CHMP has now recommended the approval of Enhertu as a monotherapy for the treatment of unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors in adult patients who have received prior treatment and who have no satisfactory treatment options available.
The positive CHMP opinion was based on data from three phase II studies, namely – DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. Data from these studies showed that treatment with Enhertu led to clinically meaningful responses across a broad range of tumors.
If approved, Enhertu would become 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.
AZN’s Price Performance
Year to date, shares of AstraZeneca have risen 1.8% against the industry’s decline of 0.3%.
Image Source: Zacks Investment Research
More on AZN, Daiichi’s Development Activities With Enhertu
Enhertu is presently approved for the second-line treatment of patients with HER2-positive breast cancer in more than 85 countries, including the United States. It is also approved in HER2-targeted indications for lung and gastric cancers.
Enhertu, in combination with Roche’s (RHHBY - Free Report) Perjeta (pertuzumab), is also approved as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer in the United States.
Earlier this month, the FDA approved Enhertu for two new breast cancer indications – for the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer.
In the neoadjuvant setting, Enhertu, followed by taxane, RHHBY’s Herceptin (trastuzumab) and Perjeta (pertuzumab) or THP, is now approved to treat adults with HER2-positive stage II or III breast cancer.
In the adjuvant setting, Enhertu is now approved for treating adults with HER2-positive breast cancer who still have invasive disease following treatment with RHHBY’s Herceptin (with or without Perjeta) and taxane-based therapy.
Enhertu in combination with Perjeta is currently under review in the EU for the first-line treatment of patients with unresectable or metastatic HER2-positive (IHC 3+ and ISH+) breast cancer, as well as for patients with HER2-positive (IHC 3+ and ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.
CHMP Backs EU Approval of AZN’s Camizestrant Combo
In a separate press release, AstraZeneca announced that the EMA’s CHMP has issued a positive opinion recommending the EU approval of camizestrant in combination with a CDK4/6 inhibitor for first-line treatment of a certain type of breast cancer.
The CHMP has recommended approval of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the treatment of adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor.
The CHMP nod was based on data from the phase III SERENA-6 study. Data from the same showed that treatment with camizestrant plus CDK4/6 inhibitor reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumor mutation.
The camizestrant combo in this setting is currently under review in the United States, Japan and several other countries.
AZN Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents to earnings of 11 cents. IMCR stock has lost 16.9% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, 2026 loss per share estimates for Jasper Therapeutics have narrowed from $3.25 to $1.64, while the same for 2027 have narrowed from $2.19 to $1.09. JSPR stock has plunged 50.6% year to date.
Jasper Therapeutics’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 5.00%.
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AZN, Daiichi's Enhertu Gets Positive CHMP Opinion for Solid Tumors
Key Takeaways
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending the EU approval of their blockbuster antibody-drug conjugate (ADC), Enhertu, for certain solid tumours.
The CHMP has now recommended the approval of Enhertu as a monotherapy for the treatment of unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors in adult patients who have received prior treatment and who have no satisfactory treatment options available.
The positive CHMP opinion was based on data from three phase II studies, namely – DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. Data from these studies showed that treatment with Enhertu led to clinically meaningful responses across a broad range of tumors.
If approved, Enhertu would become 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.
AZN’s Price Performance
Year to date, shares of AstraZeneca have risen 1.8% against the industry’s decline of 0.3%.
Image Source: Zacks Investment Research
More on AZN, Daiichi’s Development Activities With Enhertu
Enhertu is presently approved for the second-line treatment of patients with HER2-positive breast cancer in more than 85 countries, including the United States. It is also approved in HER2-targeted indications for lung and gastric cancers.
Enhertu, in combination with Roche’s (RHHBY - Free Report) Perjeta (pertuzumab), is also approved as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer in the United States.
Earlier this month, the FDA approved Enhertu for two new breast cancer indications – for the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer.
In the neoadjuvant setting, Enhertu, followed by taxane, RHHBY’s Herceptin (trastuzumab) and Perjeta (pertuzumab) or THP, is now approved to treat adults with HER2-positive stage II or III breast cancer.
In the adjuvant setting, Enhertu is now approved for treating adults with HER2-positive breast cancer who still have invasive disease following treatment with RHHBY’s Herceptin (with or without Perjeta) and taxane-based therapy.
Enhertu in combination with Perjeta is currently under review in the EU for the first-line treatment of patients with unresectable or metastatic HER2-positive (IHC 3+ and ISH+) breast cancer, as well as for patients with HER2-positive (IHC 3+ and ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.
CHMP Backs EU Approval of AZN’s Camizestrant Combo
In a separate press release, AstraZeneca announced that the EMA’s CHMP has issued a positive opinion recommending the EU approval of camizestrant in combination with a CDK4/6 inhibitor for first-line treatment of a certain type of breast cancer.
The CHMP has recommended approval of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the treatment of adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor.
The CHMP nod was based on data from the phase III SERENA-6 study. Data from the same showed that treatment with camizestrant plus CDK4/6 inhibitor reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumor mutation.
The camizestrant combo in this setting is currently under review in the United States, Japan and several other countries.
AZN Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) and Jasper Therapeutics (JSPR - Free Report) , each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents to earnings of 11 cents. IMCR stock has lost 16.9% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, 2026 loss per share estimates for Jasper Therapeutics have narrowed from $3.25 to $1.64, while the same for 2027 have narrowed from $2.19 to $1.09. JSPR stock has plunged 50.6% year to date.
Jasper Therapeutics’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 5.00%.