Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says the U.S. Food and Drug Administration has approved Verzenio in combination with endocrine therapy for the treatment of certain early-stage breast cancer. The company says the treatment is showing success in the treatment of adult patients with HR+ HER2- high risk early breast cancer.
Lilly says Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
“Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options,” said Jacob Van Naarden, chief executive officer of Loxo Oncology at Lilly and president, Lilly Oncology.
Lilly says the monarchE trial is a randomized study in adult women and men with HR+ HER2-, node-positive, resected EBC with clinical and pathological features consistent with a high risk of disease recurrence.
“This FDA approval for Verzenio in combination with endocrine therapy in the early breast cancer setting has the potential to become a new standard of care for this population,” said Dr. Sara Tolaney, Harvard Medical School and investigator on the monarchE study. “We are encouraged by the marked reduction in the risk of recurrence even beyond the two-year treatment period in these patients.”
Verzenio is a non-chemotherapy oral tablet.