Ribociclib

Recent cancer research breakthroughs include Oncolytics Biotech's BRACELET-1 study showing promising results for pelareorep in HR+/HER2- breast cancer, Novartis AG's FDA approval of Kisqali for early-stage breast cancer, Lantheus Holdings' positive Phase 3 SPLASH trial results for 177Lu-PNT2002 in prostate cancer, Sutro Biopharma's encouraging Phase 1b study data for Luvelta in ovarian cancer, and Zymeworks' upcoming presentation of preclinical data on its antibody-drug conjugate programs.

FDA approves Kisqali (ribociclib) for early stage HR-positive, HER2-negative breast cancer, in combination with hormone therapy. Kisqali, a CDK4/6 inhibitor, aims to slow cancer progression by targeting over-activated proteins. Administered orally in a 3-week on, 1-week off cycle for 3 years, it carries side effects like neutropenia and liver issues.

The FDA approved ribociclib (Kisqali) in combination with an aromatase inhibitor as an adjuvant treatment for HR+/HER2- stage 2 and 3 early breast cancer patients at high risk of recurrence, including those with node-negative disease. The approval was based on the NATALEE trial, which showed a 25.2% reduction in invasive disease-free survival risk with ribociclib plus aromatase inhibitor compared to aromatase inhibitor alone. Ribociclib therapy should continue for 3 years and is well-tolerated at a 400 mg dose.

FDA approves Kisqali for early-stage breast cancer, reducing recurrence risk by 25%. Phase III trial showed a 25.1% reduction, with a 28.5% risk reduction after four years. Dr. Dennis J. Slamon calls it a 'pivotal moment in improving our approach to care.'

FDA approves Kisqali for early-stage HR-positive, HER2-negative breast cancer, reducing recurrence risk by 25% when taken with aromatase inhibitors for 3 years.

The FDA expanded approval of Kisqali, a CDK4/6 inhibitor, for early-stage HR-positive, HER2-negative breast cancer, reducing recurrence risk by 28.5% after four years when combined with endocrine therapy. This approval broadens access to a broader patient group compared to similar drugs like Verzenio, which is limited to high-risk cases. The cost of Kisqali over three years is approximately $300,000-$400,000, but insurance coverage is expected to increase.

FDA approves Novartis’ Kisqali for early breast cancer at high risk of recurrence, including node-negative disease, potentially adding $3B to annual sales. Kisqali now covers a broader population than competitor Lilly’s Verzenio. Based on NATALEE trial results, Kisqali plus endocrine therapy showed a 25.1% reduction in recurrence risk.

Novartis' Kisqali gains broad FDA approval for early HR+/HER2- breast cancer, reducing recurrence risk by 25% in NATALEE trial, surpassing Eli Lilly's Verzenio in node-negative cases. Kisqali's potential to reach $7 billion in sales is boosted by this approval.

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