Agilent Technologies Inc. (NYSE: A) today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered. This is the first IHC assay measuring Ki-67 expression to receive FDA approval in the context of treatment with Verzenio and was developed in collaboration with Eli Lilly and Company. 

Understanding the risk of recurrence in EBC is vital for informing disease management, as identifying patients at high risk can provide clarity for patients as well as facilitate treatment decisions to potentially improve outcomes. Conventional methods for evaluating the risk of recurrence in EBC are based on staging and are performed according to standard clinical and pathological features of the disease. However, these standard features may not capture the full risk of recurrence for individuals with EBC.

The American Joint Committee on Cancer has identified the Ki-67 biomarker as Level of Evidence III in diagnosing EBC due to its association with cellular proliferation. Ki-67 is thus an important component of comprehensive risk assessment, but it has been inconsistently applied in the past.1

“Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis) companion diagnostic assay for the Dako Omnis advanced staining platform has been designed and tested to aid in evaluating risk of recurrence in early breast cancer (EBC),” said Sam Raha, president of Agilent's Diagnostics and Genomics Group. “Its approval establishes a clinically relevant standard for recurrence risk assessment in EBC so that more high-risk patients who may experience clinical benefit from treatment with Verzenio are identified.”

This approval builds on Agilent's previous successes in expanding the clinical applicability of therapeutic biomarker analysis, further cementing the company's position as a provider of diagnostic assays that deliver high quality and ease of implementation.

Reference: 1. Hortobagyi, G. N.; Connolly, J. L.; D'Orsi, C. J.; Edge, S. B.; Mittendorf, E. A.; Rugo, H. S.; Solin, L. J.; Weaver, D. L.; Winchester, D. J.; Giuliano, A. Eighth Edition of the AJCC Cancer Staging Manual: Breast Cancer. J. Am. Coll. Surg. 2018, 589–636.