Tags : HR+/HER2-

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

Novartis’ Piqray (alpelisib) + Fulvestrant Receive FDA’s Approval for Patients

Shots: The approval is based on P-III SOLAR-1 study result assessing Piqray (alpelisib) + Fulvestrant vs Fulvestrant in 572 postmenopausal women/men in ratio (1:1) with PIK3CA-mutated HR+/HER2- advanced/m-breast cancer, following aromatase inhibitor prior treated with/without CDK4/6 inhibitor The P-III SOLAR-1 study result: mPFS (11.0 mos. vs 5.7mos.); ORR (35.7% vs 16.2%). Piqray & its associated […]Read More

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

Shots: The P-III MONALEESA trials (MONALEESA-2, 3,7) involved assessing of Kisqali (ribociclib) + endocrine therapy vs endocrine therapy alone in patients with visceral metastases in pre, peri- and postmenopausal women with HR+/HER2- advanced breast cancer P-III MONALEESA study results: (MONALEESA-2, 3,7) mPFS (11.5 mos., 16.5 mos., 13.4 mos.), mORR (53%, 48%, 50% vs 40%, 31%, […]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