Novartis announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on its cancer drug Kisqali for reducing the risk of recurrence in patients with early-stage HR+/HER2- breast cancer. This recommendation is based on the Phase III Natalee study, which showed that Kisqali (ribociclib) added to endocrine therapy reduced the risk of recurrence by 25% compared to hormonal treatment alone.
In the public statement released by the Swiss pharmaceutical giant, the CHMP highlighted that endocrine therapy, when used for pre- or peri-menopausal patients as well as male patients, should be accompanied by a luteinizing hormone-releasing hormone agonist. The main advisory committee of the European Medicines Agency also suggested removing references to HR+/HER2- and the combination with a luteinizing hormone-releasing hormone agonist from the product information for indications against advanced or metastatic stages of the disease.
In September, Kisqali was approved by the US Food and Drug Administration (FDA) for this purpose. The European Commission is expected to make its final decision within approximately two months following the CHMP recommendation.
This positive development underscores the potential of Kisqali in providing improved outcomes for patients with HR+/HER2- breast cancer. The recommendation from the CHMP signals a step forward in expanding treatment options and addressing unmet medical needs in this patient population. Patients and healthcare providers alike will be eagerly awaiting the final decision from the European Commission to make this innovative therapy more widely available.