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 (NCT01958021), a randomized, double-blind study that enrolled 668 postmenopausal patients with HR+/HER2-  advanced breast cancer, showed that combining Kisqali with Femara cut by 44 percent the risk of disease progression or death, compared to Femara alone.

Femara, an aromatase inhibitor that blocks estrogen production in postmenopausal women, has been a standard of care in early-stage and advanced breast cancer for more than a decade.

U.S. physicians will now be able to prescribe Kisqali via the Co-Pack, as two separate prescriptions, or Kisqali with any aromatase inhibitor including Arimidex (anastrozole) and Aromasin (exemestane). The Co-Pack prescription includes a full 28-day cycle of the two medicines in one co-pay. In addition, the Co-Pack is sold at the same price as Kisqali alone.

The Co-Pack will be available later this month in three distinct dosages, combining Femara 2.5 mg with either Kisqali 600 mg, Kisqali 400 mg, or Kisqali 200 mg.


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