Shots: The P-III MONALEESA-7 trial involves assessing Kisqali + endocrine therapy (goserelin + either an aromatase inhibitor or tamoxifen) as initial treatment vs endocrine therapy alone in patients with HR+/HER2- […]readmore
Tags : Kisqali
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 […]readmore
Shots: Novartis’ Kisqali + endocrine therapy has achieved 5 out of 5 scores on ESMO-MCBS, confirming substantial benefit for premenopausal women with HR+/HER2- aBC, based on OS benefit and improved […]readmore
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 […]readmore
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 […]readmore
Shots: The NICE approval is based on P-III MONALEESA-3 study results assessing Kisqali + fulvestrant vs fulvestrant as monothx. in patients with HR+/HER2- LA or metastatic breast cancer prior treated […]readmore
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 […]readmore
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 […]readmore
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- […]readmore
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- […]readmore