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AstraZeneca Secures FDA Nod for New Breast Cancer Therapy Etcamah
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Key Takeaways
AZN's Etcamah won accelerated approval with CDK4/6 inhibitors for certain advanced breast cancer patients.
The combination cut the risk of disease progression or death by 56% versus standard-of-care treatment.
The FDA also approved Guardant360 CDx to identify patients with ESR1 mutations for the new therapy.
AstraZeneca (AZN - Free Report) announced that the FDA has approved Etcamah (camizestrant) in combination with a medicine belonging to the class of cyclin-dependent kinase (CDK) 4/6 inhibitors for the treatment of certain patients with advanced breast cancer. The approval was granted under the accelerated pathway.
The agency has approved the combination therapy to treat patients with hormone receptor (HR)-positive, HER2-negative breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). Etcamah is to be used in combination with any of the three blockbuster CDK4/6 inhibitors: Pfizer’s (PFE - Free Report) Ibrance (palbociclib), Novartis’ (NVS - Free Report) Kisqali (ribociclib), and Eli Lilly’s (LLY - Free Report) Verzenio (abemaciclib).
The FDA approval is supported by results from the phase III SERENA-6 study, which showed that combining Etcamah with a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% versus standard-of-care treatment (hormone therapy plus a CDK4/6 inhibitor).
The FDA decision comes after a regulatory review that included an April 2026 meeting of one of its advisory committees, which did not reach a majority vote in favor of the benefit of the Etcamah combination. After AstraZeneca provided additional data at the agency’s request, which included analyses of circulating tumor DNA (ctDNA) clearance and longer-term efficacy outcomes, the agency extended the review period by an additional three months.
AZN Sets Eyes on Breast Cancer Market
Per AstraZeneca, this is its 10th FDA approval so far this year and the fourth in a breast cancer indication. The company’s first three breast cancer approvals include Datroway for triple-negative breast cancer, as well as Enhertu in two early-stage HER2-positive breast cancer settings.
In the United States, breast cancer is the most common cancer among women, with more than 300,000 new patients diagnosed annually and over 42,000 deaths. The significant patient population and substantial unmet treatment needs make breast cancer an important market for AstraZeneca.
AZN Stock Performance
Year to date, shares of AstraZeneca have lost 11.5% against the industry’s 10% growth.
Image Source: Zacks Investment Research
More on AZN’s Etcamah
Etcamah is a potent, next-generation oral selective estrogen receptor degrader (SERD) and complete estrogen receptor (ER) antagonist. SERDs work by binding to and degrading the estrogen receptor, helping block estrogen-driven signaling involved in the growth of HR-positive breast cancer.
AstraZeneca is evaluating Etcamah across a broad clinical development program, including the phase III SERENA-4, CAMBRIA-1 and CAMBRIA-2 studies. These studies are evaluating the drug both as a monotherapy and in combination with CDK4/6 inhibitors in different treatment settings for patients with HR-positive, HER2-negative breast cancer, supporting the company’s efforts to expand the potential use of the drug beyond its current indication.
FDA Also Approves Diagnostic Test to Support AZN’s Cancer Combo
Alongside Etcamah approval, the agency has also approved a companion diagnostic test called Guardant360 CDx to identify patients with breast cancer harboring ESR1 mutations for treatment with the newly approved combination therapy. The test was developed by Guardant Health as part of its collaboration with AstraZeneca.
Guardant Health and AstraZeneca have a multi-year collaboration focused on integrating Guardant’s diagnostic capabilities into the clinical development of AstraZeneca’s cancer therapies. Guardant360 CDx was also used in the SERENA-6 study to enable serial ctDNA testing and support the treatment-switch strategy evaluated in the study.
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AstraZeneca Secures FDA Nod for New Breast Cancer Therapy Etcamah
Key Takeaways
AstraZeneca (AZN - Free Report) announced that the FDA has approved Etcamah (camizestrant) in combination with a medicine belonging to the class of cyclin-dependent kinase (CDK) 4/6 inhibitors for the treatment of certain patients with advanced breast cancer. The approval was granted under the accelerated pathway.
The agency has approved the combination therapy to treat patients with hormone receptor (HR)-positive, HER2-negative breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). Etcamah is to be used in combination with any of the three blockbuster CDK4/6 inhibitors: Pfizer’s (PFE - Free Report) Ibrance (palbociclib), Novartis’ (NVS - Free Report) Kisqali (ribociclib), and Eli Lilly’s (LLY - Free Report) Verzenio (abemaciclib).
The FDA approval is supported by results from the phase III SERENA-6 study, which showed that combining Etcamah with a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% versus standard-of-care treatment (hormone therapy plus a CDK4/6 inhibitor).
The FDA decision comes after a regulatory review that included an April 2026 meeting of one of its advisory committees, which did not reach a majority vote in favor of the benefit of the Etcamah combination. After AstraZeneca provided additional data at the agency’s request, which included analyses of circulating tumor DNA (ctDNA) clearance and longer-term efficacy outcomes, the agency extended the review period by an additional three months.
AZN Sets Eyes on Breast Cancer Market
Per AstraZeneca, this is its 10th FDA approval so far this year and the fourth in a breast cancer indication. The company’s first three breast cancer approvals include Datroway for triple-negative breast cancer, as well as Enhertu in two early-stage HER2-positive breast cancer settings.
In the United States, breast cancer is the most common cancer among women, with more than 300,000 new patients diagnosed annually and over 42,000 deaths. The significant patient population and substantial unmet treatment needs make breast cancer an important market for AstraZeneca.
AZN Stock Performance
Year to date, shares of AstraZeneca have lost 11.5% against the industry’s 10% growth.
Image Source: Zacks Investment Research
More on AZN’s Etcamah
Etcamah is a potent, next-generation oral selective estrogen receptor degrader (SERD) and complete estrogen receptor (ER) antagonist. SERDs work by binding to and degrading the estrogen receptor, helping block estrogen-driven signaling involved in the growth of HR-positive breast cancer.
AstraZeneca is evaluating Etcamah across a broad clinical development program, including the phase III SERENA-4, CAMBRIA-1 and CAMBRIA-2 studies. These studies are evaluating the drug both as a monotherapy and in combination with CDK4/6 inhibitors in different treatment settings for patients with HR-positive, HER2-negative breast cancer, supporting the company’s efforts to expand the potential use of the drug beyond its current indication.
FDA Also Approves Diagnostic Test to Support AZN’s Cancer Combo
Alongside Etcamah approval, the agency has also approved a companion diagnostic test called Guardant360 CDx to identify patients with breast cancer harboring ESR1 mutations for treatment with the newly approved combination therapy. The test was developed by Guardant Health as part of its collaboration with AstraZeneca.
Guardant Health and AstraZeneca have a multi-year collaboration focused on integrating Guardant’s diagnostic capabilities into the clinical development of AstraZeneca’s cancer therapies. Guardant360 CDx was also used in the SERENA-6 study to enable serial ctDNA testing and support the treatment-switch strategy evaluated in the study.
AstraZeneca PLC Price
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AZN’s Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.