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[SITUATION] · [ACTIVE] · [HEALTH]

2 clusters · 7 sources · 4 days · First seen · Last updated

FDA breast cancer treatment approvals

Overview

The U.S. Food and Drug Administration (FDA) has issued approvals for new breast cancer treatments targeting advanced or metastatic cases.

Initial approvals included AstraZeneca’s Etcamah (camizestrant), an oral selective estrogen receptor degrader (SERD) for hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer with an ESR1 gene mutation. The FDA also approved palbociclib in combination with trastuzumab and endocrine therapy for HR+ and HER2-positive patients, following clinical trials showing extended progression-free survival.

Subsequently, the FDA granted accelerated approval for Etcamah when used in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with HR+, HER2-negative locally advanced or metastatic breast cancer who develop an ESR1 mutation. This approval, based on the Phase III SERENA-6 trial, noted a 56% reduction in the risk of disease progression or death compared to standard treatment. Additionally, the FDA cleared a companion diagnostic to detect ESR1 resistance mutations in circulating tumor DNA to assist in therapeutic adjustments.

Entities

AstraZeneca · FDA · Etcamah · palbociclib · Winship Cancer Institute of Emory University

Timeline

  1. 4 days ago

    [HEALTH] 4 sources
    AstraZeneca's Etcamah receives FDA accelerated approval for breast cancer

    The FDA has granted accelerated approval to AstraZeneca’s Etcamah combination therapy for treating certain advanced or metastatic HR-positive, HER2-negative breast cancers with ESR1 mutations.

  2. 8 days ago

    [HEALTH] 3 sources
    FDA approves new breast cancer treatments

    The FDA has approved two new treatment options for advanced or metastatic breast cancer: AstraZeneca’s Etcamah for ESR1-mutated tumors and palbociclib for HR+/HER2+ patients.

Sources

2001online.com · cancernetwork.com · immedicohospitalario.es · pharmaceutical-business-review.com · pmlive.com · saludiario.com · xeu.mx