Novartis announced this week that the FDA has approved ribociclib (marketed as Kisqali) for the treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive,

An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.

Novartis NVS announced positive data on breast cancer drug Kisqali (ribociclib) from the late-stage study, NATALEE. This late-breaking data from this four-year post-hoc analysis was presented at the European Society for Medical Oncology (“ESMO”) Congress 2024.

The potential market for the Novartis drug Kisqali could grow markedly, now that certain early-stage breast cancer patients will be able to receive it.

The Food and Drug Administration expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat patients with earlier stages of the disease, drugmaker Novartis said Tuesday.

The US Food and Drug Administration (FDA) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence,

Women with early stage breast cancer may now take Kisqali, a medication already approved for advanced disease.

The FDA approval of Kisqali for this early breast cancer population, including those with NO [hasn't spread to nearby lymph nodes] disease, is a pivotal moment in improving our approach to care,” said Dr.

Vas Narasimhan, CEO of Novartis, comments on the progress of the firm's Kisqali metastatic breast cancer drug after the company recently received an extended approval for it from the U.S. Food and Drug Administration.