FDA Approves Co-Packaging of Kisqali With Femara to Treat Metastatic Breast Cancer

The Food and Drug Administration (FDA) has approved co-packaging of the oral medications Kisqali (ribociclib) and Femara (letrozole) that are used to treat HR-positive, HER2-negative advanced breast cancer in postmenopausal women.

With the new Kisqali® Femara® Co-Pack, patients can obtain a full 28-day cycle of the two medicines in one package with one prescription and one copay, and the cost will be the same as that for Kisqali alone, according to Novartis, which manufactures both medications.

“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,” said Bill Hinshaw, executive vice president and U.S. head of Novartis Oncology, in a statement announcing the approval.

The company noted that Kisqali, which helps to slow cancer progression by inhibiting the cyclin-dependent kinase 4 and 6 (CDK 4/6) proteins, can continue to be prescribed separately along with another aromatase inhibitor (AI).

The CDK 4/6 inhibitor Kisqali was approved by the FDA March 13 for use in combination with an AI for this population of women, based on findings for the phase 3 MONALEESA-2 trial. In that study, the combination reduced the risk of progression or death by 44 percent compared with Femara alone in the first-line setting for HR+/HER2- advanced breast cancer.

Additionally, 53 percent of patients with measurable disease who received the Kisqali-Femara combination experienced a reduction in tumor burden of at least 30 percent.

“This is a significant result for women with this serious form of breast cancer," according to MONALEESA-2 principal investigator Gabriel N. Hortobagyi, M.D., professor of medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center.

In the trial, Kisqali did add to treatment-associated toxicity, as 59.3 percent of patients who received the CDK 4/6 inhibitor developed grade 3/4 neutropenia — a low white blood cell count that can lead to infection — as compared with 0.9 percent of patients who received placebo. Grade 3/4 leukopenia occurred in 21 percent of the Kisqali arm and 0.6 percent of the placebo group. Hematologic adverse events were uncomplicated and resolved without incident in most cases.

The most common nonhematologic adverse events (all grades) were nausea (51.5 percent with Kisqali versus 28.5 percent with placebo), infections (50.3 percent versus 42.4 percent), fatigue (36.5 percent versus 30 percent) and diarrhea (35 percent versus 22.1 percent). The events were grade 1/2 severity in most cases.

MONALEESA-2 represents a paradigm shift for the management of HR+/HER2- advanced breast cancer, because at some point, all breast cancers will become resistant to endocrine therapy alone.

The CDK 4/6 inhibitor also proved effective in a subgroup of patients in this trial of women aged 65 years or older. The novel regimen was well tolerated among a MONALEESA-2 elderly subgroup, with a safety profile similar to that of the overall study population. Despite a higher rate of patients with an ECOG performance status of 1, the elderly population also had dose interruption and reduction rates consistent with the overall trial results, reported Lowell L. Hart, M.D., of Florida Cancer Specialists, at the 2017 Miami Breast Cancer Conference.

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.

Novartis announced that the co-pack will be available in the United States later this month at both specialty and retail pharmacies, and does not change the indication for either medicine.