Subscribe

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive:

NEW INDICATIONS

Verzenio with Endocrine Therapy FDA Approved for Adjuvant Treatment of Early Breast Cancer

JHOP - December 2021 Vol 11, No 6 - FDA Oncology Update
Download PDF

On October 12, 2021, the FDA approved the combination of abemaciclib (Verzenio; Eli Lilly) plus endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor (HR)-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA-approved test. Abemaciclib is the first CDK4/6 inhibitor to receive FDA approval for adjuvant treatment of breast cancer.

On the same day, the FDA also approved the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay as a companion diagnostic test for selecting appropriate patients for this combination therapy.

This approval was based on the monarchE study, a randomized, open-label, 2-cohort multicenter clinical trial. The study included women and men with HR-positive, HER2-negative, node-positive, resected, early breast cancer and clinical and pathological features consistent with a high risk for disease recurrence. Patients were randomized in a 1 to 1 ratio to 2 years of abemaciclib plus their physician’s choice of endocrine therapy or to endocrine therapy alone.

The primary end point was invasive disease-free survival (IDFS). In the 2003 patients with high risk for disease recurrence and Ki-67 score ≥20%, the use of abemaciclib plus endocrine therapy showed significant improvement in IDFS (hazard ratio, 0.626; 95% confidence interval [CI], 0.488-0.803; P = .0042) versus endocrine therapy alone. At 36 months, the IDFS was 86.1% (95% CI, 82.8-88.8) with abemaciclib plus endocrine therapy compared with 79.0% (95% CI, 75.3-82.3) with endocrine therapy alone. The overall survival data were not mature at the time of the analysis.

The most common (≥20%) side effects were diarrhea, infections, neutropenia, fatigue, leukopenia, nausea, anemia, and headache.

Related Items
Kymriah Received Accelerated FDA Approval for Relapsed or Refractory Follicular Lymphoma
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update, Lymphoma
Tibsovo Received a New Indication, in Combination with Azacitidine, for Newly Diagnosed Patients with AML and IDH1 Mutation
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update
Vidaza Received New Indication for Patients with Newly Diagnosed Juvenile Myelomonocytic Leukemia
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update
Enhertu Received Regular FDA Approval for Patients with Unresectable or Metastatic Breast Cancer
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update
Yescarta First CAR T-Cell Therapy FDA Approved for Large B-Cell Lymphoma
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update
Pluvicto FDA Approved for PSMA-Positive Metastatic Prostate Cancer
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Opdualag, a Novel Immunotherapy Combination, FDA Approved for Advanced Melanoma
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Carvykti Second BCMA-Directed CAR T-Cell Therapy FDA Approved for Multiple Myeloma
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Keytruda Monotherapy FDA Approved for Endometrial Carcinoma with a Biomarker
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Lynparza Receives FDA Approval for Adjuvant Treatment of High-Risk Early Breast Cancer with BRCA Mutation
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.