Ribociclib Active Across Premenopausal Breast Cancer Subgroups

Excerpt:

“The progression-free survival (PFS) benefit for ribociclib (Kisqali) in pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer was sustained across patient subgroups, according to findings from the phase III MONALEESA-7 trial presented at the 2018 Miami Breast Cancer Conference.

“MONALEESA-7 randomized patients to either the CDK4/6 inhibitor ribociclib in combination with tamoxifen or a nonsteroidal aromatase inhibitor (NSAI; letrozole or anastrozole) plus goserelin (n = 335), or to endocrine treatment plus goserelin (n = 337). Across the overall study population, the median PFS was 23.8 months for the ribociclib arm compared with 13.0 months for the control arm (HR, 0.553; 95% CI, 0.441-0.694; P <.0001).”

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US Awards Novartis’ Kisqali ‘Breakthrough’ Status

Excerpt:

“Novartis’ CDK4/6 inhibitor Kisqali has picked up Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer.

“The US Food and Drug Administration has awarded the designation for of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.”

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In Young Women With Metastatic Breast Cancer, Kisqali Delays Tumor Growth And Relieves Symptoms

Excerpt:

“At this year’s San Antonio Breast Cancer Symposium, several reports on new treatments for advanced breast cancer caught my attention. In an impressive analysis presented by Dr. Debu Tripathy, ribociclib (Kisqali, Novartis) extended progression-free survival (PFS) and improved the quality of life in young women with metastatic hormone receptor (HR) positive, HER2 negative tumors.

“Ribociclib meets ‘a clear and unmet need for premenopausal patients with HR positive, HER2 negative advanced breast cancer,’ Tripathy said at the press meeting in San Antonio. Novartis sponsored the MONALEESA-7 trial in which 672 eligible women with metastatic disease were randomized to receive hormone-blocking agents with either ribociclib or a placebo. The study registered women between age 25 and 58; the median age was around 44 years; the groups were divided evenly. The international study includes metastatic breast cancer patients in North and South America, Europe, Asia and Australia.”

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Novartis Takes Fight to Pfizer’s Ibrance with New Kisqali Data

Excerpt:

“New data from Novartis’s breast cancer drug Kisqali underscored its effectiveness in pre-menopausal women, the Swiss drugmaker said, amid efforts to muscle in on turf dominated by rival Pfizer’s Ibrance.

“A late-stage trial showed Kisqali, in concert with hormonal therapies, halted the advance of hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer in pre-menopausal women for longer than in women getting hormonal therapy alone, Novartis said on Wednesday.”

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FDA Approves Co-Packaging of Ribociclib With Letrozole for Metastatic Breast Cancer

Excerpt:

“The FDA has approved co-packaging of the oral medications ribociclib (Kisqali) and letrozole (Femara) for the treatment of postmenopausal women with HR-positive, HER2-negative advanced breast cancer.

“With the new Kisqali Femara Co-Pack, patients can obtain a full 28-day cycle of the 2 medicines in 1 package with 1 prescription and 1 copay, and the cost will be the same as that for Kisqali alone, according to Novartis, which manufactures both medications.”

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Ribociclib Response Unaffected by Prior Treatment

Excerpt:

“The FDA recently approved ribociclib (Kisqali) for use in combination with an aromatase inhibitor as initial therapy for treatment of postmenopausal women with HR+/HER2-negative advanced or metastatic breast cancer.

“Ribociclib, an inhibitor of CDK4/6, was approved based on data from the phase III MONALEESA-2 trial, which was ended early following the first preplanned interim analysis. In this analysis, the combination of ribociclib and the aromatase inhibitor letrozole met the trial’s primary endpoint by demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone.”

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Novartis Kisqali® (Ribociclib, LEE011) Receives FDA Approval as First-Line Treatment for HR+/HER2- Metastatic Breast Cancer in Combination with Any Aromatase Inhibitor

Excerpt:

“The US Food and Drug Administration (FDA) has approved Kisqali®(ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

“Kisqali is a CDK4/6 inhibitor approved based on a first-line Phase III trial that met its primary endpoint early, demonstrating statistically significant improvement in progression-free survival (PFS) compared to letrozole alone at the first pre-planned interim analysis. Kisqali was reviewed and approved under the FDA Breakthrough Therapy designation and Priority Review programs.”

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