'Kisqali' Updates: Novartis Drug Receives FDA Approval As First-Line Treatment For Metastatic Breast Cancer

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Mar 18, 2017 01:38 PM EDT

Latest updates have revealed that the United States Food and Drug Administration (FDA) have approved Novartis drug as a first-line treatment for patients with breast cancer. According to reports, Novartis AG revealed on Monday that the Food and Drug Administration had approved the company's experimental drug called Kisqali (ribociclib, formerly known as LEE011).

He noted that the drug was approved as a first-line treatment for a type of breast cancer that is common in postmenopausal women. The drug will be used in treating the codion in combination with another breast cancer drug.

The new breast cancer drug will be used in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, who have been diagnosed with metastatic breast cancer or hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced.

According to Times of Indian, the recent approval of the drug is based on a late-stage data that revealed that Kisqali, which will be combined with letrozole during the breast cancer treatment met the main goal of progression-free survival at an interim analysis when compared to breast cancer patients treated with letrozole alone. It is also reported that the company revealed that more than half of the breast cancer patients taking Kisqali along with letrozole were able to stay alive and progression-free during the period of the interim analysis.

According to Reuters, Novartis' Kisqali is an oral drug, which aids to slow down the progression of cancer by inhibiting two proteins known as cyclin-dependent kinase 4 and 6 (CDK4/6). The report stated that these two proteins can cause breast cancer cells to grow and divide too quickly when over-activated.

The new breast cancer treatment drug can be taken with or without food as a once-daily oral dose of 600 mg for three weeks. This is followed by a week off treatment. Kisqali is taken during the period of the treatment along with four weeks of any aromatase inhibitor (letrozole).

The new drug which targets CDK4/6 is said to work actively to ensure that the breast cancer cells do not continue to grow and replicate uncontrollably. It is reported that breast cancer is currently the second most common cancer among American women. It is also estimated by the American Cancer Society that more than 250,000 women will be diagnosed with invasive breast cancer in 2017. Up to one-third of patients who have already been diagnosed with early-stage breast cancer will subsequently develop metastatic disease.

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