Kisqali gets early breast cancer approval in Europe

Novartis has unlocked another growth driver for its fast-growing breast cancer therapy Kisqali with EU approval as an adjuvant therapy for patients with early-stage disease.

The European Commission has cleared use of CDK4/6 inhibitor Kisqali (ribociclib) to reduce the risk of recurrence in patients with stage 2 or 3, HR-positive/HER2-negative early breast cancer, based on the results of the NATALEE trial.

The green light in Europe comes a few weeks after Kisqali was cleared for this indication in the US and will raise the competitive pressure on class rival Verzenio (abemaciclib) from Eli Lilly, which claimed a similar adjuvant indication last year.

The two drugs are both big sellers, with Kisqali growing 43% to $787 million in the third quarter, while Verzenio grew by 32% to $1.36 billion, and are also used as first- and second-line therapies for advanced HR+/HER2- breast cancer.

Novartis' drug has been benefitting from the launch in early breast cancer and its Category 1 recommendation in National Comprehensive Cancer Network (NCCN) guidelines for HR+/HER2- metastatic breast cancer.

It is currently the only drug in the CDK4/6 inhibitor class with that level of recommendation as a first-line therapy in combination with an aromatase inhibitor for advanced cases of this form of breast cancer and was added to the guidance for adjuvant use last month.

Novartis has estimated that the early breast cancer indication doubles the number of patients that are eligible for Kisqali versus its use in metastatic disease and, according to chief executive Vas Narasimhan, is "a three times larger population than is currently labelled for the competitor product in the class in early breast cancer."

In the NATALEE trial, adding Kisqali to standard treatment with adjuvant endocrine therapy (ET) resulted in a 25.1% reduction in the risk of cancer recurrence compared to ET alone after three years of follow-up.

"For many patients diagnosed with stage 2 or 3 HR+/HER2- early breast cancer, the risk of their cancer coming back despite treatment with endocrine therapy remains high, even after decades," said Michael Gnant of the Medical University of Vienna, Austria, who is president of the Austrian Breast and Colorectal Study Group.

"This approval represents a positive milestone for the early breast cancer community in Europe, including physicians who now have a new option to help reduce the risk of recurrence in a broader population of patients," he added.

Around 70% of breast cancer cases in Europe are diagnosed at the early stages and the five-year survival rate for this group is pretty high overall at 99%. However, between 30% and 60% of patients with stage 2 or 3 HR+/HER2- early breast cancer will eventually see their cancer return.