FDA has approved a combination package containing two prescription drugs for advanced breast cancer. Novartis reports that FDA has approved the Kisqali Femara Co-Pack, calling it the "first and only" currently available combination pack with two prescription products for advanced breast cancer: ribociclib tablets and letrozole tablets.
According to a news release issued by Novartis, 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 cancer. Femara is an aromatase inhibitor approved for first-line treatment of postmenopausal women with HR+ or unknown advanced breast cancer; it has been available for nearly 20 years, and research by Novartis has continued during this time, it was reported.
A spokesperson tells PMP News that Novartis is doing the packaging internally. The combination package contains a 28-day cycle of the two medicines. It can be obtained with one prescription and with one copay, making the Kisqali Femara Co-Pack available at the same cost as Kisqali alone, according to the release. It 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.
“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,” stated Bill Hinshaw, Executive Vice President and Head, US, Novartis Oncology, in the 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.”
The Kisqali Femara Co-Pack will be available in the United States later this month at both specialty and retail pharmacies.
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