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Global pharmaceutical company Novartis has announced that its brand of ribociclib (Kisqali®) has achieved regulatory approval in Europe for treatment of breast cancer.

This development comes after the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recently recommended Kisqali as a Category 1 preferred adjuvant treatment for breast cancer.

The Swiss firm has confirmed that the European Commission has authorized Kisqali in combination with an aromatase inhibitor for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence.

"We are proud of this approval, which will help to address a key unmet need and improve health outcomes for a broader population of patients in Europe," emphasized Iris Zemzoum, M.D., President, Europe, Novartis.

As a selective cyclin-dependent kinase inhibitor, ribociclib slows the spread of cancer by blocking two proteins known as cyclin-dependent kinase 4 and 6 (CDK4/6).

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RELATED: Novartis Kisqali® has received FDA approval to lower recurrence risk in patients with HR+/HER2-early breast cancer.

 

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When these proteins are overactive, they can promote the rapid growth and division of cancer cells.

Enhancing the precision of CDK4/6 targeting could help prevent cancer cells from proliferating unchecked.

This European approval is based on data from a global phase III study coded NATALEE, which found that among a broad patient population with HR+/HER2- stage II and III EBC, administration of ribociclib in combination with endocrine therapy resulted in a “significant and clinically meaningful” efficacy level compared to endocrine therapy alone.

Patients on adjuvant ribociclib experienced a 25.1% reduction in risk of cancer recurrence compared to those who didn’t receive the therapy.

"Adding a new treatment option to the HR+/HER2- early breast cancer armamentarium is encouraging news for both physicians and their patients—including patients with node-negative disease and additional risk factors. Ribociclib may now help many patients who are at risk of their cancer returning," stated Michael Untch, M.D., Director of the Interdisciplinary Breast Cancer Center at Helios Klinikum Berlin-Buch.

Only a few months back, Kisqali—developed by Novartis through a research collaboration with Astex Pharmaceuticals—gained regulatory approval from the US Food and Drug Administration and is now authorized in over 100 countries worldwide as a treatment option for metastatic breast cancer.

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