The U.S. Food and Drug Administration (FDA) has granted Kisqali (ribociclib) Breakthrough Therapy designation for the treatment of premenopausal women with HR-positive, HER2-negative advanced breast cancer who have not received prior endocrine treatment, according to Novartis.
The designation, designed to expedite the development and review of treatments for serious or life-threatening conditions, was granted to Kisqali in combination with tamoxifen or an aromatase inhibitor.
Kisquali is approved in the U.S., the E.U., and many other countries for postmenopausal women with HR-positive, HER2-negative metastatic breast cancer. Novartis is seeking approval of the therapy for women who have not reached menopause or who are in menopause transition (perimenopausal).
The FDA’s Breakthrough Therapy designation for Kisqali in premenopausal women with advanced cancer was based on positive results from the MONALEESA-7 Phase 3 trial (NCT02278120), which were presented in December at the San Antonio Breast Cancer Symposium (SABCS).
“This Breakthrough Therapy designation reflects the significance and promise of the MONALEESA-7 data presented at SABCS last month,” Samit Hirawat, MD, head of Novartis Oncology Global Drug Development, said in a press release.
“Younger women often have distinct treatment goals and needs, and it is important for oncologists to offer effective and well-studied treatment options for their specific disease,” Hirawat said. “We look forward to working with FDA to make this combination therapy available to premenopausal women living with HR+/HER2- advanced breast cancer in the U.S. as soon as possible.”
The MONALEESA-7 trial enrolled 672 women ages 25 to 58 with advanced or metastatic breast cancer whose tumors were positive for the hormone receptor (HR) but negative for the human epidermal growth factor receptor-2 (HER2).
The study was designed to evaluate whether adding Kisqali to tamoxifen or an aromatase inhibitor plus goserelin could increase the time a patient lived without their disease worsening.
Participants were randomized to receive either tamoxifen or an aromatase inhibitor – Femara (letrozole) or Arimidex (anastrozole) – plus goserelin, with or without Kisqali.
The addition of Kisqali significantly increased patients’ progression-free survival (PFS), compared to the hormone therapy alone – 19.2 months vs. 13.0 months.
But the extent of Kisqali’s benefit depended on the combination used, researchers found. For patients given tamoxifen plus goserelin, the addition of Kisqali increased the median PFS from 11.0 months to 22.1 months. Patients who received an aromatase inhibitor plus goserelin, however, saw their median PFS increase from 13.8 months to 27.5 months when Kisqali was added to the combination.
During the MONALEESA-7 trial, no new safety signals were detected.