Abemaciclib FDA approval : Eli Lilly and Company (Lilly) has secured the US FDA approval for Verzenio (abemaciclib) to treat metastatic breast cancer in patients whose disease had progressed after a prior treatment.
Abemaciclib FDA Approval
The breast cancer drug approval is for patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative. And the new breast cancer drug approved is for those patients in whom the disease had progressed after being subject to a therapy that changes their hormones (endocrine therapy).
The US drug regulator stated that it has approved Verzenio in combination with fulvestrant. This is for patients in whom breast cancer had grown on endocrine treatment.
Verzenio FDA Approval
According to a press release on the abemaciclib FDA approval, patients can also be given the breast cancer drug on its own if they were treated with endocrine therapy and chemotherapy in the past after their cancer had grown.
Commenting on the Verzenio FDA approval, Richard Pazdur of the FDA said: “Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy.”
Richard Pazdur is the director of the FDA’s Oncology Center of Excellence. He is also the acting director of the Office of Hematology and Oncology Products in the US drug regulator’s Center for Drug Evaluation and Research.
How Lilly Breast Cancer Drug Works
Lilly breast cancer drug Verzenio is an inhibitor of as cyclin-dependent kinases 4 and 6 which are known for promoting cancer cells growth in the body.
In March, Lilly reported that its breast cancer drug Verzenio in combination with fulvestrant endocrine therapy had significantly improved progression-free survival in a phase 3 trial known as MONARCH 2.
Following the abemaciclib FDA approval, Lilly is reportedly looking to launch the new breast cancer drug branded as Verzenio in October in the US.