Tags : Kisqali

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study

Shots: The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI population & across exploratory subgroups, m-OS was not reached while […]Read More

Novartis Reports the Reimbursement of Kisqali as 1L Treatment for

Shots: The reimbursement of Kisqali is a testament to the ongoing need for public access to the treatment. The Canadian Province, Quebec will reimburse Kisqali + Letrozole under the public drug program as 1L treatment for HR+, HER2-negative advanced or metastatic breast cancer in post-menopausal women Novartis will collaborate with remaining province and territories in […]Read More

Novartis Reports Results of Kisqali in Second Phase P-III MONALEESA-3

Shots: The P-III MONALEESA-3 study involves assessing of Kisqali (ribociclib) + fulvestrant in postmenopausal women with HR+/HER2- advanced or m-breast cancer The second phase of P-III MONALEESA-3 study resulted in meeting its 2EPs of OS with no new observed safety signals and consistent AEs with the previous P-III study results. These results follow MONALEESA-7 study results […]Read More

Novartis Reports Result of Kisqali (ribociclib) + Endocrine Therapy in

Shots: The P-III MONALEESA-7 study results involves assessing of Kisqali in combination with endocrine therapy (goserelin + aromatase inhibitor/tamoxifen) vs endocrine therapy as monothx. in pre- and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer The P-III MONALEESA-7 study resulted in improving survival rate @42mos. (70.2% vs 46.0%), 30%/20.9% reduction in risk of death, […]Read More

Insights+: Breakthrough Therapy Designation by the US FDA in 2018

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to the drugs as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available therapies […]Read More

Novartis’ Kisqali (ribociclib) (as a Combination Therapy) Receives CHMP’s Expanded

Shots: 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 […]Read More

Novartis’ Kisqali + Aromatase Inhibitor Receive FDA’s Breakthrough Therapy Designation

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 […]Read More