FDA approves Novartis breast cancer treatment

EAST HANOVER, N.J. — Novartis announced that the Food and Drug Administration has approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women. According to Novartis, the Kisqali Femara Co-Pack is the first, and only currently available, combination pack with two prescription products in advanced breast cancer.

With this FDA approval, physicians in the United States now have the flexibility to prescribe Kisqali two different ways: via the new Co-Pack or as two separate prescriptions of Kisqali and any aromatase inhibitor.

"As we strive to keep the patient at the center 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," said Bill Hinshaw, EVP and head, US, Novartis Oncology. "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."

The packaging of the Kisqali Femara Co-Pack allows patients the convenience of obtaining a full 28-day cycle of the two medicines in one package with one prescription and one co-pay. The Kisqali Femara Co-Pack is available at the same cost as Kisqali alone.

The Kisqali Femara Co-Pack is available in three dosage strengths: Kisqali 600 mg plus Femara 2.5 mg, Kisqali 400 mg plus Femara 2.5 mg, and Kisqali 200 mg plus Femara 2.5 mg.