FDA Approves Ribociclib-Letrozole Co-Pack for Initial Treatment of HR-positive/HER2-negative Advanced or Metastatic Breast Cancer

The first, and only currently available, combination pack with two prescription products in advanced breast cancer

On 8 May, 2017 Novartis announced that the US Food and Drug Administration (FDA) has approved the ribociclib (Kisqali®)- letrozole (Femara®) co-pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER-2)-negative advanced or metastatic breast cancer in postmenopausal women. It is the first co-pack, 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.

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 13 March, 2017 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer. Femara is an aromatase inhibitor approved for first-line treatment of postmenopausal women with HR-positive or unknown advanced breast cancer.

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). 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 under a research collaboration with Astex Pharmaceuticals.

Femara® (letrozole) is an aromatase inhibitor. It was first approved in 1997 for treatment of postmenopausal women with HR-positive or unknown advanced breast cancer that progressed after anti-oestrogen therapy. In 2001, Femara was approved as first-line treatment of postmenopausal women with HR-positive or unknown locally advanced or metastatic breast cancer. Femara has been available for nearly 20 years.

Kisqali or the Kisqali Femara co-pack can cause a QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Kisqali or the Kisqali Femara co-pack can cause serious liver problems. Low white blood cell counts are very common when taking Kisqali or the Kisqali Femara co-pack and may result in infections that may be severe. Before taking Kisqali or the Kisqali Femara co-pack, patients should tell their health care provider if they are pregnant, or plan to become pregnant as Kisqali or the Kisqali Femara co-pack can harm an unborn baby. Females who are able to become pregnant and who take Kisqali or the Kisqali Femara co-pack should use effective birth control during treatment and for at least 3 weeks after the last dose. Do not breastfeed during treatment with Kisqali or the Kisqali Femara co-pack and for at least 3 weeks after the last dose. Patients should tell their healthcare provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements since they may interact with Kisqali. Patients should avoid pomegranate or pomegranate juice, and grapefruit or grapefruit juice while taking Kisqali or the Kisqali Femara co-pack.

The most common side effects (incidence ≥20%) of Kisqali plus letrozole are white blood cell count decreases, nausea, tiredness, diarrhoea, hair thinning or hair loss, vomiting, constipation, headache, and back pain. The most common grade 3/4 side effects in the Kisqali plus letrozole arm (incidence >2%) were low neutrophils, low leukocytes, abnormal liver function tests, low lymphocytes, and vomiting.

The Novartis release contains forward-looking statements.