Approvals

Last month, the Committee for Medicinal products for Human Use (CHMP), which is part of the European Medicines Agency (EMA) announced that it has adopted a positive opinion for Novartis’ Kisquali (ribociclib) as an adjuvant in the treatment of adults with hormone receptor-positive/human epidermal growth factor 2negative (HR+/HER2-) early breast cancer (EBC).

The decision from CHMP is based on the results from the phase 3 NATALEE trial, which showed that Kisquali, in addition to endocrine therapy, lowered the risk of cancer recurrence by 21.1% in patients with stage 2 and 3 HR+/HER2EBC. This was in comparison to endocrine therapy alone. Kisquali also demonstrated a consistent and clinically meaningful invasive disease-free survival. The safety profile of the drug showed that the dosage, 400mg, was well tolerated with ‘generally low-grade symptomatic adverse events’, according to the press release.

Patrick Horber MD and president, International, Novartis said “Today, many people diagnosed with HR+/HER2early breast cancer in Europe lack options beyond endocrine therapy to help reduce their risk of cancer coming back. If approved, Kisqali could nearly double the number of patients eligible for CDK4/6 inhibitor adjuvant therapy.”

Kisquali was approved by the US Food and Medicines Agency (FDA) in September earlier this year.

Principle investigator and MD, professor of Translational Medicine, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN, Germany, Peter A Fasching stated: “One-third of people diagnosed with stage 2 breast cancer and more than half of those diagnosed with stage 3 will unfortunately experience a return of their cancer in the long term, often as metastatic disease. Kisqali could provide an effective and tolerable adjuvant treatment option to mitigate the risk of recurrence in a broader patient population, particularly for patients who currently have limited treatment options, including those with high-risk node-negative disease.”

CHMP has also recommended granting marketing authorisation for Kisquali. The European Commission is expected to make a decision regarding the approval within two months.