FDA Approves Kisqali Femara Co-Pack to Treat Subset of Advanced Breast Cancer Patients

FDA Approves Kisqali Femara Co-Pack to Treat Subset of Advanced Breast Cancer Patients
The U.S. Food and Drug Administration (FDA) has approved Novartis Oncology's Kisqali Femara Co-Pack for to treat postmenopausal women with hormone receptor-positive, HER2-negative (HR+/HER2-) advanced or metastatic breast cancer. The Co-Pack, which includes Kisqali (ribociclib) tablets plus Femara (letrozole) tablets, is the first combination pack with two prescription products for advanced breast cancer patients. This approval comes less than two months after the FDA approved Kisqali, in combination with an aromatase inhibitor, as the first endocrine-based therapy to treat breast cancer patients. "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," Bill Hinshaw, executive vice-president at Novartis Oncology, said in a press release. "Providing physicians a convenient one-package prescribing option for their patients underscores our commitment to deliver innovative treatment solutions to the metastatic breast cancer community." Kisqali is a selective inhibitor of the CDK4/6 proteins, which when overactive can lead to unregulated proliferation of cancer cells. Targeting CDK4/6 with high precision may halt the uncontrolled replication of those cells. Interim results from the MONALEESA-2 Phase 3 trial (
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