Novartis receives FDA approval for Kisqali Femara Co-Pack to treat metastatic breast cancer
Novartis has received the US Food and Drug Administration (FDA) approval for the Kisqali Femara Co-Pack to treat hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+ / HER2-) advanced or metastatic breast cancer in postmenopausal women.
The company claimed that Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) is the only available combination pack with two prescription products in advanced breast cancer.
Novartis oncology executive vice president and US head Bill Hinshaw said: “As we strive to keep the patient at the centre of every decision that we make at Novartis, we are pleased that collaborating closely with the FDA has resulted in our being able to offer this unique combination pack of two prescription cancer medicines.
“Providing physicians with a convenient one-package prescribing option for their patients underscores our commitment to deliver innovative treatment solutions to the metastatic breast cancer community.”
Kisqali (ribociclib) is a selective, cyclin-dependent kinase inhibitor that decelerates the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6).
It is developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
Femara (letrozole) is a form of hormone therapy known as an aromatase inhibitor, which reduces the amount of oestrogen produced in the bodies of postmenopausal women.
The approval will allow the US physicians to prescribe Kisqali as the new Co-Pack or as two separate prescriptions and any aromatase inhibitor.
The Kisqali Femara Co-Pack will be made available in three dosage strengths by the end of this month in the US at both specialist and retail pharmacies.