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

 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

Shots:

  • 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

Tuba Khan

Tuba Khan is an Editor and Digital Marketing expert at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in Lifesciences industry. She covers Pharma, Medical devices, Diagnostics and Digital health segment. Tuba also has an experience of digital and social media marketing and can run the campaign independently. She is also certified as a Digital marketer and social media marketer. She can be contacted on tuba@pharmashots.com

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