Abemaciclib is approved by FDA with endocrine therapy for early breast cancer

October 2021: The Food and Drug Administration has approved abemaciclib (Verzenio, Eli Lilly and Company) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of less than 20%, as determined by an FDA- This is the first CDK 4/6 inhibitor to be approved for breast cancer adjuvant treatment.

Agilent, Inc. submitted the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay, which was authorised by the FDA as a companion diagnostic for this indication.

Adult women and men with HR-positive, HER2-negative, node-positive, resected, early breast cancer with clinical and pathological characteristics consistent with a high risk of disease recurrence were involved in monarchE (NCT03155997), a randomised (1:1), open-label, two-cohort multicenter trial. Patients were given either 2 years of abemaciclib plus their doctor’s choice of standard endocrine medication or normal endocrine therapy alone.

Invasive disease-free survival was the primary effectiveness outcome measure (IDFS). The trial found a statistically significant improvement in IDFS (HR 0.626; 95 percent CI: 0.488, 0.803; p=0.0042) in patients with a high risk of recurrence and a Ki-67 Score of less than 20% (N=2003). Patients receiving abemaciclib with tamoxifen or an aromatase inhibitor had an IDFS of 86.1 percent (95 percent CI: 82.8, 88.8) at 36 months, while those receiving tamoxifen or an aromatase inhibitor had an IDFS of 79.0 percent (95 percent CI: 75.3, 82.3). At the time of the IDFS analysis, the overall survival data was not complete.

Diarrhea, infections, neutropenia, tiredness, leukopenia, nausea, anaemia, and headache were the most prevalent side effects (20%).

The recommended beginning dose of abemaciclib is 150 mg twice daily in combination with tamoxifen or an aromatase inhibitor for 2 years or until disease recurrence or intolerable toxicity, whichever comes first.

Nishant Mittal (PhD)

+ postsBio ⮌

Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.

Research Highlights

Dr. Mittal's research has focused on several key areas:

1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.

2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.

4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.

Publications and Presentations

Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.

In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.

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