FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer

Breast Cancer News

FDA OKs Adjuvant Ribociclib in Earlier Stage Breast Cancer
Malignant Breast NeoplasmBreast CarcinomaHER2 Negative Breast Cancer
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Unlike rival CDK 4/6 inhibitor abemaciclib, patients don't need to be lymph-node positive to receive ribociclib after surgery.

ribociclib in combination with an aromatase inhibitor for adult patients with HR-positive, HER2-negative stages II and III breast cancer at high-risk for recurrence following surgery.

There's no such restriction for the new ribociclib indication, which"allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people," lead investigatorThe new indication joins ribociclib's previous approval for advanced or metastatic hormone receptor -positive, human epidermal growth factor receptor 2 -negative breast cancer in combination with an aromatase inhibitor or fulvestrant.

Invasive disease-free survival at 36 months was 90.7% in the ribociclib arm vs 87.6% with aromatase inhibitor monotherapy , the ribociclib group continued to do better, with an invasive disease-free survival rate of 88.5% vs 83.6% in the control arm.

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Malignant Breast Neoplasm Breast Carcinoma HER2 Negative Breast Cancer HER2- Breast Cancer Aromatase Inhibitor Exemestane Breast Mammary Gland Cancer Malignant Neoplasia Carcinoma Malignant Neoplasm Genomics Genomic Medicine Lymph Nodes Surgery Hepatic Surgery Liver Surgery Epidermal Growth Factor Receptor EGFR - Epidermal Growth Factor Receptor EGFR Receptors

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