FDA approves ribociclib plus letrozole to treat a subset of advanced breast cancer patients.
FDA approved ribociclib plus letrozole (Kisqali Femara Co-Pack, Novartis) for initial treatment of hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) advanced or metastatic breast cancer.
The combination pack allows patients the convenience of obtaining a full 28-day cycle of the 2 medicines in one package and is available at the same cost of Kisqali alone.
“For the first time, patients living in the United States who are prescribed the combination will have the option of receiving one single prescription that provides them with both medicines, Kisqali and Femara, under one copay,” said Bill Hinshaw, executive vice president and head, US, Novartis Oncology.
Ribociclib is a selective cyclin-dependent kinase inhibitor that helps slow the progression of cancer by inhibiting cyclin-dependent kinase 4 and 6 (CDK4/6), which when over-activated can enable cancer cells to grow and divide quickly. Femara is an aromatase inhibitor, which works by reducing the amount of estrogen produced in the bodies of postmenopausal women. Letrozole (Novartis) Femara has been available for more than 20 years and in 2001, it was approved as first-line treatment of postmenopausal women with HR+ or unknown locally advanced or metastatic breast cancer.
It is available in 3 dosage strengths: Kisqali 600 mg/Femara 2.5 mg, Kisaqali 40 mg/Femara 2.5 mg, and Kisqali 200 mg/Femara 2.5 mg.
According the Hinshaw, Kisqali is the only CDK4/6 inhibitor approved based on a first-line, phase 3 trial that met its primary endpoint early, demonstrating significant improvement in progression-free survival (PFS) compared to letrozole alone at the first pre-planned interim analysis. In the MONALEESA-2 trial, more than half of patients with measurable disease taking Kisqali plus letrozole experienced a tumor burden reduction of at least 30% and treatment benefit was consistent across all patient subgroups regardless of disease burden or tumor location.
Some of the most common side effects associated with the use of Kisqali plus letrozole were neutropenia, nausea, tiredness, diarrhea, alopecia, headache and back pain. Serious adverse reactions associated with Kisqali or the Kisqali Femara Co-Pack include QT prolongation, neutropenia and serious liver problems. Kisqali can also harm an unborn baby and females who are able to become pregnant and who take Kisqali or the Kisqali Femara Co-Pack should use effective birth control during treatment and for at least 3 weeks after the last dose.
The Kisqali Femara Co-Pack will be available at both specialty and retail pharmacies.