The U.S. Food and Drug Administration designated Novartis’ breast cancer drug Kisqali as a “breakthrough therapy,” giving the Swiss pharmaceutical a chance to get priority review upon significant clinical results.

The breakthrough designation comes as the second for the drug. Kisqali first got the status in August 2016 based on the MONALEESA-2 trial.

The latest designation comes from results of phase 3 MONALEESA-7 trial conducted on 672 women with hormone-receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer, the company said.

"This Breakthrough Therapy designation reflects the significance and promise of the MONALEESA-7 data presented at SABCS last month," said Samit Hirawat, head of Novartis Oncology Global Drug Development

MONALEESA-7 pitted a Kisqali, Zoladex (goserelin), and an endocrine therapy combination (tamoxifen or an aromatase inhibitor) against an endocrine therapy and Zoladex combo, the company said.

Results showed the Kisqali arms notably prolonged median progression-free survival (PFS) compared to the endocrine therapy group (23.8 months vs. 13 months). Specifically, the Kisqali, tamoxifen, and goserelin arm showed a 22.1-month median PFS compared to 11 months for the tamoxifen and goserelin arm.

The Kisqali, aromatase inhibitor, and goserelin combination demonstrated 27.5 months median PFS compared to 13.8 months with the aromatase inhibitor and goserelin combo, the company said.

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