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FDA Approves Combo of Abemaciclib, Endocrine Therapy for Early Breast Cancer
The FDA approved the combination of abemaciclib and either tamoxifen or an aromatase inhibitor as an adjuvant treatment for some adults with HR-positive, HER2-negative, node-positive, early breast cancer.
This approval marks the first CDK 4/6 inhibitor for adjuvant treatment of breast cancer, according to the agency.
The approval is for patients with a high risk of recurrence and a Ki-67 score of ≥20%, according to a release from the agency.
As part of the designation, the FDA approved the Ki-67 IHC MIB-1 pharmDx assay as a companion diagnostic.
The agency utilized results from the monarchE trial, which randomized patients to either two years of abemaciclib and endocrine therapy or endocrine therapy alone. The major efficacy outcome of the trial was invasive disease-free survival (IDFS).
The trial showed patients with a high risk of recurrence and Ki-67 score ≥20% had a statistically significant improvement in the IDFS (HR 0.626; 95% CI: 0.488-0.803; p=0.0042).
The IDFS at 36 months was 86.1% (95% CI: 75.3-82.3) for patients receiving tamoxifen or an aromatase inhibitor. The results for overall survival were “not mature at the time of the IDFS analysis.”
In reviewing the safety of the treatment, the FDA noted that the most common adverse reactions included diarrhea, infections, and neutropenia.
The starting dose is 150 mg twice daily in combination with tamoxifen or an aromatase inhibitor until completion of two years of treatment or until disease recurrence, or unacceptable toxicity, according to the release.
Reference:
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-endocrine-therapy-early-breast-cancer?utm_medium=email&utm_source=govdelivery
Images: Getty Images, Pixabay
By Adam Hochron
This approval marks the first CDK 4/6 inhibitor for adjuvant treatment of breast cancer, according to the agency.
The approval is for patients with a high risk of recurrence and a Ki-67 score of ≥20%, according to a release from the agency.
As part of the designation, the FDA approved the Ki-67 IHC MIB-1 pharmDx assay as a companion diagnostic.
The agency utilized results from the monarchE trial, which randomized patients to either two years of abemaciclib and endocrine therapy or endocrine therapy alone. The major efficacy outcome of the trial was invasive disease-free survival (IDFS).
The trial showed patients with a high risk of recurrence and Ki-67 score ≥20% had a statistically significant improvement in the IDFS (HR 0.626; 95% CI: 0.488-0.803; p=0.0042).
The IDFS at 36 months was 86.1% (95% CI: 75.3-82.3) for patients receiving tamoxifen or an aromatase inhibitor. The results for overall survival were “not mature at the time of the IDFS analysis.”
In reviewing the safety of the treatment, the FDA noted that the most common adverse reactions included diarrhea, infections, and neutropenia.
The starting dose is 150 mg twice daily in combination with tamoxifen or an aromatase inhibitor until completion of two years of treatment or until disease recurrence, or unacceptable toxicity, according to the release.
Reference:
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-endocrine-therapy-early-breast-cancer?utm_medium=email&utm_source=govdelivery
Images: Getty Images, Pixabay
By Adam Hochron