Eli Lilly's CDK 4/6 in early stage HR+/HER2- breast cancer
March 06, 2023 - Eli Lilly’s Verzenio doesn’t need results from a biomarker test to treat certain patients with early breast cancer, and it can reach metastatic disease regardless of menopausal status.
The FDA has removed the Ki-67 score requirement for selecting patients with HR-positive, HER2-negative early breast cancer for Verzenio treatment after surgery, Lilly said Friday. Now, eligible patients who’re deemed at high risk of recurrence don’t need a high Ki-67 score but are only defined by commonly used standards around lymph node involvement and tumor size and grade.
Pfizer's Ibrance and Novartis' Kisquali are the other CDK 4/6 inhibitors that are approved for use in the treatment of breast cancer.
https://www.fiercepharma.com/marketing/fda-widens-lilly-verzenio-breast-cancer-removes-test-menopausal-status
However, since their approval, clinical evidences have demonstrated that about 30% of breast cancer is intrinsically resistant to CDK4/6 inhibitors and that prolonged treatment eventually leads to acquired resistance in many patients.
https://www.frontiersin.org/articles/10.3389/fonc.2022.891580/full
CDK 4/6 inhibitors are a class of small molecules that can be also be combined with ONCY's pelareorep to overcome the acquired resistance described above.