Ribociclib FDA label updated to include pre- and perimenopausal women

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Ribociclib now approved for use in pre- and perimenopausal women with HR-positive, HER2-negative ABC

By: News Feed | Last updated: 19th July 2018 | In: Breast Cancer, Endocrine Therapy, Oncology, Targeted Therapies, US FDA Onc\Haem Approvals

Article Keywords

ABC, aromatase inhibitor, AstraZeneca, CDK4/6, endocrine therapy, Faslodex, FDA, fulvestrant, goserelin, HER2-negative, hormonal therapy, HR-positive, Kysqali, MBC, Novartis, NSAI, postmenopausal, premenopausal, ribociclib, tamoxifen

On July 18, 2018, the US FDA expanded the ribociclib (Kysqali©, Novartis) approval. Ribociclib plus an aromatase inhibitor as initial endocrine-based therapy is no longer limited to postmenopausal HR-positive, HER2-negative advanced or metastatic breast cancer patients alone and now includes pre- and perimenopausal women ¹. Furthermore, the FDA has added the combination ribociclib plus fulvestrant as initial endocrine-based therapy for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.

Ribociclib in pre- and perimenopausal women

The randomised, double-blind, placebo-controlled MONALEESA-7 trial (NCT02278120) randomised 672 HR-positive, HER2-negative pre- and perimenopausal women who had not received endocrine therapy for advanced disease ². Patients were randomised to ribociclib plus goserelin and either a non-steroidal aromatase inhibitor (NSAI) or tamoxifen vs placebo plus goserelin and either an NSAI or tamoxifen.

A pre-specified NSAI-only subgroup analysis (N=495) resulted in a median progression-free survival (PFS, RECIST 1.1) of 27.5 months for patients on the ribociclib plus NSAI plus goserelin compared with 13.8 months for those on the placebo plus NSAI plus goserelin (HR=0.57; 95% CI, 0.44-0.74).

Ribociclib is not indicated for concomitant use with tamoxifen.

Ribociclib plus fulvestrant

Another randomised double-blind, placebo-controlled study, the MONALEESA-3 (NCT02422615), investigated the combination ribociclib plus fulvestrant in 726 postmenopausal HR-positive, HER2-negative, advanced breast cancer patients who had received up to one line of prior endocrine treatment ³. The median PFS for the ribociclib plus fulvestrant group was 20.5 months compared with 12.8 months for patients treated with placebo plus fulvestrant (HR=0.59; 95% CI, 0.48-0.73; P<0.001).

Common adverse reactions in ≥20% of patients treated with ribociclib are neutropenia, nausea, infections, fatigue, diarrhoea, leukopenia, vomiting, alopecia, headache, constipation, rash and cough. More information.

References

View full prescribing information for Kisqali©

Tripathy D, et al. Lancet Oncol 2018;19(7):DOI:10.1016/S1470-2045(18)30292-4

Slamon DJ, et al. J Clin Oncol 2018;36:DOI:10.1200/JCO.2018.78.9909

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).