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Kisqali

Novartis' Kisqali reinforces overall survival benefit in postmenopausal HR+/HER2- breast cancer

New Phase 3 evidence has emerged on the efficacy of Novartis’ Kisqali (ribociclib) in combination with AstraZeneca’s Faslodex (fulvestrant) in the first- and second-line treatment of hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women.

The findings showed that the combo “achieved statistically significant improvement in overall survival”, building on previous trial results that showed its benefit in prolonging life in patients. No additional safety signals were discovered.

NICE greenlights Novartis Kisqali combo in HR+/HER2- advanced breast cancer

Novartis’ Kisqali (ribociclib) has secured recommendation from NICE in combination with fulvestrant, meaning the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor will be immediately made available on the NHS.

The drug will be accessible to an estimated 5,300 patients a year in England and Wales, where exemestane plus everolimus is the most appropriate alternative, as a treatment for women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer who have received prior endocrine therapy.  

Novartis' Kisqali combo boosts survival in HR+/HER2- advanced breast cancer

Novartis took the opportunity at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting to reveal new Phase 3 data on Kisqali (ribociclib) in combination with endocrine therapy (either an aromatase inhibitor or tamoxifen) in the initial treatment of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in pre- and perimenopausal women.

The findings, taken from 672 premenopausal, HR+ or HER2- breast cancer patients under 59, revealed that the Kisqali combo improved overall survival rates by 70.2

Novartis' Kisqali combo rejected by NICE for advanced breast cancer

Novartis’ Kisqali (ribociclib) has been rejected for use on the NHS by NICE for the treatment of advanced breast cancer, the organisation has announced.  

Specifically, the drug was turned down in combination with fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in patients who have had previous endocrine therapy.

Novartis’ Kisqali gains breakthrough status in premenopausal breast cancer

Novartis has received a major boost in its efforts to broaden use of its CDK4/6 inhibitor, by receiving a breakthrough status from the FDA in evaluating its potential for use in premenopausal women with breast cancer.

Novartis Kisqali improves PFS in younger women

A Phase 3 trial looking at the use of Kisqali (ribociclib) to treat premenopausal or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer was found to significantly boost progression-free survival (PFS).

The trial saw Kisqali being used in combination with tamoxifen or an aromatase inhibitor, plus AZ’s Zoladex. This combination treatment was compared against the same regimen, except with a placebo standing in for Kisqali.

NICE approves Novartis and Pfizer’s rival breast cancer drugs

NICE has announced that it has given the nod to two new treatments for breast cancer with the approval of Pfizer’s Ibrance (palbociclib) and Novartis’ Kisqali (ribociclib).

The news marks a rapid turnaround for Novartis drug, with a NICE approval coming only months after its August European Commission Approval, and means that it enters the UK market at the same time as Pfizer’s rival CDK4/6 inhibitor.

Novartis' Kisqali smashes Phase 3 primary endpoint in breast cancer for second time

Novartis has revealed that its immunotherapy drug Kisqali (ribociclib) met its primary endpoint of progression-free survival in its second Phase 3 trial.

The therapy was tested in combination with oral hormonal therapies and goserelin in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer, comparing its efficacy against endocrine treatment alone.

The trial is the first in 20 years to show the success of a CDK4/6 inhibitor in such a combination in this patient group.

Novartis secures first-line FDA approval in breast cancer indication

The FDA has approved Kisqali (ribociclib) in combination with letrozole for the first-line treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

The approval was based on a Phase 3 trial wherein the combination was able to show greater efficacy than letrozole alone. The primary endpoint was based on progression-free survival (PFS), and found that the combination improved survival by 44% over letrozole alone.

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