AstraZeneca Secures FDA Nod for New Breast Cancer Therapy Etcamah

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  "company": {
    "name": "AstraZeneca",
    "domain": "astrazeneca.com"
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    "url": "https://www.theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/4474761/astrazeneca-secures-fda-nod-for-new-breast-cancer-therapy-etcamah/",
    "title": "AstraZeneca Secures FDA Nod for New Breast Cancer Therapy Etcamah - The Globe and Mail",
    "excerpt": "AstraZeneca AZN 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 Ibrance (palbociclib), Novartis ’ NVS Kisqali (ribociclib), and Eli Lilly ’s LLY 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...",
    "product": "Etcamah",
    "summary": "AstraZeneca is evaluating its breast cancer drug Etcamah in several phase III studies (SERENA-4, CAMBRIA-1, CAMBRIA-2) to potentially expand its use as both a monotherapy and in combination treatments.",
    "planning": true,
    "image_url": "https://www.theglobeandmail.com/pf/resources/assets/meta/twitter-summary-240x240.png?d=956",
    "confidence": 0.9,
    "product_data": {
      "name": "Etcamah",
      "full_text": "Etcamah",
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      "medical"
    ],
    "published_at": "2026-09-07T14:14:14Z",
    "article_sentence": "AstraZeneca is evaluating Etcamah across a broad clinical development program, including the phase III SERENA-4, CAMBRIA-1 and CAMBRIA-2 studies."
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