FDA Approves Novartis Kisqali As Metastatic Breast Cancer Treatment

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Fresh hope for women suffering from metastatic breast cancer after the onset of menopause: the latest drug developed by Novartis AG to combat this condition has just been approved as first-line treatment for the disease.

The new drug, Kisqali, is part of an endocrine-based therapy designed to fight an advanced type of breast tumor known as HR+/HER2-, with high prevalence among postmenopausal cancer patients.

Reports by the American Cancer Society reveal approximately 40 percent of U.S. women battling breast tumors are affected by metastatic breast cancer.

The Swiss pharmaceutical company announced in a press release the recently approved medication — available in pill form — targets two proteins that activate the growth and division process of cancer cells, reducing the spread of the tumor.

Novartis, a leading company in the development of cancer medicines, also indicates Kisqali is intended to be administered alongside a previously issued cancer drug called letrozole, which follows a different course of action in battling breast tumors.

“This is an important therapy for these patients” who are faced with limited therapeutic options, said Dr. Vas Narasimhan, chief medical officer and head of drug development at Novartis.

The U.S. Food and Drug Administration confirmed the approval of Kisqali, which belongs to a class of pharmaceuticals called kinase inhibitors, on March 13.

Costs And Treatment Cycles

Kisqali and letrozole work as a combination treatment, spanning for a four-week therapy cycle. Kisqali is intended to be administered every day during the first three weeks, following a one-week pause.

In the course of the four weeks, patients are also given letrozole, which can be substituted for another aromatase inhibitor, contingent on the aspects of their condition.

According to Novartis, a month’s supply of Kisqali, respectively 21 pills, will be listed at prices varying from $10,950 for the strongest dose (600 milligrams), $8,760 for the 400-milligram dose, and $4,380 for the 200-milligram dose.

Since women suffering from metastatic breast cancer generally need to go from one dose to another, the 200-milligram variant of the pill is estimated to be more cost effective.

In addition, the Swiss drug manufacturer disclosed its plans to offer patients various types of financial assistance, thus allowing many women to avoid making co-payments.

Possible Side Effects

A clinical study involving 668 women determined that the combination treatment of Kisqali plus letrozole has successfully decreased the risk of death as well as the exacerbation of the tumor by 44 percent. These results were monitored in comparison with patients treated only with letrozole.

The study, funded by Novartis, also allowed the Swiss company to observe and report any possible side effects of Kisqali, particularly the drugs’ active ingredient, ribociclib.

These side effects include potentially lethal abnormal heartbeat, severe hepatic problems, strong infections, nausea, hair loss, and fatigue. Kisqali is contraindicated to pregnant or breastfeeding women.

Novartis, who developed the drug in collaboration with Astex Pharmaceuticals, a subsidiary of Japan’s Otsuka Group, informs of ongoing additional studies of Kisqali in combination with other treatments for premenopausal women.

Photo: Ed Uthman | Flickr

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