Breakthrough status for Novartis’ Kisqali

Patient enrolment milestone for Anthenex’s Oraxol Phase III Study
Credit: Guschenkova

Novartis has picked up Breakthrough Therapy designation in the US for Kisqali as an initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer.

This designation is based on positive results of the Phase III MONALEESA-7 trial demonstrating Kisqali in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy significantly prolonged progression-free survival compared to endocrine therapy alone.

A total of 672 women ranging from 25-58 years in age were enrolled and randomized in the trial. All treatment combinations also included goserelin.

Treatment benefit with Kisqali combination therapy was consistent compared to the overall population regardless of treatment with tamoxifen or aromatase inhibitor endocrine partners, and across predefined patient subgroups.

This is the second such designation for Kisqali after it picked up Breathrough Therapy designation in August 2016 based on results of the Phase III MONALEESA-2 trial.