Novartis' Kisqali (ribociclib) (as a Combination Therapy) Receives CHMP's Expanded Label Recommendation for HR+/HER2- Locally Advanced or Metastatic Breast Cancer
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- The combination therapy recommendation of Kisqali plus endocrine therapy is based on results of P-III MONALEESA-7 and MONALEESA-3 trials assessing Kisqali vs endocrine therapy alone in women with HR+/HER2- Locally Advanced or Metastatic Breast Cancer
- P-III MONALEESA-7 and MONALEESA-3 study results: mPFS (27.5 mos.- 20.5 mos. vs 13.8 mos.- 12.8 mos.) as 1L or 2L treatment- no safety issues- with improvement in 8 weeks
- Kisqali is a cyclin-dependent kinase inhibitor of two proteins- i.e. cyclin-dependent kinase 4 and 6 (CDK4/6) indicated for the treatment of HR+/HER2- Locally Advanced or Metastatic Breast Cancer
Ref: Novartis| Image: Fortune
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