資料來源：https://www.prnewswire.com/news-releases/novartis-receives-fda-approval-for-first-of-its-kind-kisqali-femara-co-pack-for-initial-treatment-of-hrher2--advanced-or-metastatic-breast-cancer-300453393.html

Novartis announced today that the US Food and Drug Administration (FDA) 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 women1. 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, Executive Vice President 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 innovative 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. The Kisqali Femara Co-Pack will be available in the US later this month at both specialty and retail pharmacies, and does not change the indication for either medicine.

Kisqali was approved on March 13, 2017 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer2. Femara is an aromatase inhibitor approved for first-line treatment of postmenopausal women with HR+ or unknown advanced breast cancer3. Developed by Novartis, Femara has been a standard of care option for more than a decade in early and advanced breast cancer.

About Kisqali® (ribociclib)

Kisqali® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

About Femara® (letrozole)

Femara® (letrozole) is a form of hormone therapy known as an aromatase inhibitor, which works by reducing the amount of estrogen produced in the bodies of postmenopausal women. Femara was first approved in 1997 for treatment of postmenopausal women with HR+ or unknown advanced breast cancer that progressed after antiestrogen therapy. In 2001, Femara was approved as first-line treatment of postmenopausal women with HR+ or unknown locally advanced or metastatic breast cancer.

Femara has been available for nearly 20 years and research by Novartis has continued during this time.