Novartis Breast Cancer Drug Gets FDA OK (NVS)

Posted March 14, 2017

The drug can now be prescribed by physicians in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

Kisqali, an oral drug, helps in slowing down the progression of cancer by preventing two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6).

The trial, which included 668 postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, reduced the risk of progression or death by 44%.

The FDA has approved Novartis' Kisqali (ribociclib), in combination with an aromatase inhibitor as initial endocrine-based therapy treatment, for the treatment of breast cancer.

A once-daily oral dose of Kisqali plus letrozole reduced the risk of disease progression or death by 44 percent over letrozole alone, according to results of a study released past year.

As part of research collaboration with Astex Pharmaceuticals, the Novartis Institutes for BioMedical Research (NIBR) has developed Kisqali.

The recommended dosing of Kisqali is 600 mg daily, to be taken in three 200-mg film-coated tablets, for 21 consecutive days followed by seven days off treatment resulting in a complete cycle of 28 days. Kisqali side effects may include nausea, hair loss and fatigue, along with potentially fatal abnormal heartbeat, serious liver problems and severe infections. It can not be taken by women who are pregnant or breastfeeding.

The Swiss drugmaker's treatment comes at a lower price tag than Pfizer's Ibrance.

A Cortellis forecast, based on the estimates of 10 analysts who cover Novartis suggest that global sales of Kisqali could reach $118 million this year.

Novartis considers Kisqali to be one of its stable of 13 new medicines with blockbuster potential for annual revenue in the billions of dollars. Kisqali is expected to bring in $1.5 billion in sales by 2022, Thomson Reuters data shows. With Kisqali's release, Novartis is in close competition with Pfizer's Ibrance that also has the same function of the new drug. Two of those studies are in what is usually the last stage before seeking regulatory approval. But the company said that most health issues that arose during Kisqali's trials were mild to moderate and generally managed through interrupting or reducing the dose.