Novartis’ Kisqali + Aromatase Inhibitor Receive FDA’s Breakthrough Therapy Designation for HR+/HER2- Advanced Breast Cancer

Novartis’ LysaKare (arginine hydrochloride/lysine hydrochloride) Solution Receives CHMP’s Positive Opinion for Reduction of Kidney Exposure to Radiation During PPRT with Lutathera


  • The FDA’s BT designation is based on P-III MONALEESA-7 study assessing Kisqali + tamoxifen/ aromatase inhibitor + goserelin vs tamoxifen/aromatase inhibitor + goserelin in 672 pre/perimenopausal women with HR+/HER2- advanced breast cancer
  • The P-III MONALEESA-7 study results: mPFS (22.1, 27.5 vs 11.0, 13.8 mos.); AEs: neutropenia (60.6% vs. 3.6%); leukopenia (14.3% vs. 1.2%); no new safety signals observed
  • Kisqali (ribociclib) is a CDK4/6 (cyclin-dependent kinase) inhibitor, approved in the US for postmenopausal women with HR+/HER2- advanced or metastatic breast cancer in combination with aromatase inhibitor and has received its first BT designation based on P-III MONALEESA-2 study in Aug’16.

Click here to read full press release/ article | Ref: Novartis | Image: Value Walk