MONALEESA

MONALEESA is a clinical trial program for the cancer medication ribociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Developed by Bayer, ribociclib was first approved by the US FDA in March 2015 for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

The MONALEESA trial program consists of several studies investigating the efficacy and safety of ribociclib in combination with endocrine therapy for the treatment of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer. The trials have evaluated ribociclib in combination with letrozole, an aromatase inhibitor, and tamoxifen or a non-steroidal aromatase inhibitor, such as anastrozole.

The main results of the MONALEESA-2 and MONALEESA-3 trials, presented at the European Society for Medical Oncology (ESMO) 2016 Congress, demonstrated significant improvements in progression-free survival (PFS) when ribociclib was combined with tamoxifen or letrozole, as compared to the endocrine therapy alone. Subsequently, the US FDA and the European Medicines Agency (EMA) approved the expanded indications for ribociclib in combination with endocrine therapy.

The MONALEESA trials have also investigated the tolerability and safety of ribociclib in combination with endocrine therapy. Adverse events related to the program included neutropenia, nausea, vomiting, and diarrhea. The long-term tolerability of ribociclib, including the incidence and management of serious adverse events, continues to be assessed in ongoing extension studies.

The MONALEESA trial program has provided valuable data on the efficacy and safety of ribociclib in the treatment of HR+, HER2- advanced or metastatic breast cancer, and ribociclib has become a standard treatment option in combination with endocrine therapy.