Kisqali(ribociclib)
Oncology· 3796 cited findings· 5 source documents
Company: Novartis AG →
What the regulatory reviews say
Kisqali (ribociclib) is a drug approved by the FDA on March 13, 2017, and May 4, 2017, following a Breakthrough Therapy Designation on August 2, 2016, and December 8, 2017. The application type was sNDA 209092, Supplement-1, and it received Priority review.
In efficacy studies, the combination of LEE011 (ribociclib) and fulvestrant resulted in an average increase in tumor volume of -46.6 mm³ compared to a 412.6 mm³ average increase for the vehicle control group. The hazard ratio for invasive Disease-Free Survival (iDFS) was 0.749 (95% CI: 0.628, 0.892), with iDFS at 36 months being 90.7% and 87.6% in different arms. The median Progression-Free Survival (PFS) was 14.7 months, with a hazard ratio of 0.556 (95% CI: 0.429, 0.720) and a p-value of < 0.0001.
Safety findings include an incidence of Grade 1-2 ILD/pneumonitis of 1.5% in early breast cancer and 1.6% (any Grade) in advanced or metastatic breast cancer, with Grade 3-4 incidence at 0.4% and a fatal outcome rate of 0.1%. In early breast cancer, 0.3% of patients (8 out of 2494) had a post-baseline QTcF interval > 500 ms.
Key figures — cited to the source page
| FDA approval date | March 13, 2017 | NOVARTIS — Kisqali FDA Review (NDA/BLA 209092, 2019), p.63 |
| Average increase in tumor volume for LEE011 and fulvestrant combination group | -46.6 mm3 | NOVARTIS — Kisqali FDA Review (NDA/BLA 209092, 2019), p.234 |
| Average increase in tumor volume for vehicle control group | 412.6 mm3 | NOVARTIS — Kisqali FDA Review (NDA/BLA 209092, 2019), p.234 |
| Hazard ratio (95% CI) for iDFS | 0.749 (0.628, 0.892) | Novartis AG — Kisqali FDA Review (NDA/BLA 209092, 2026), p.31 |
| Median PFS | 14.7 months | Novartis AG — Kisqali FDA Review (NDA/BLA 209092, 2026), p.33 |
| Hazard Ratio (95% CI) for PFS | 0.556 (0.429, 0.720) | Novartis AG — Kisqali FDA Review (NDA/BLA 209092, 2026), p.33 |
| Incidence of ILD/pneumonitis (any Grade) in advanced or metastatic breast cancer | 1.6% | Novartis AG — Kisqali FDA Review (NDA/BLA 209092, 2026), p.16 |
| Percentage of patients with > 500 ms post-baseline QTcF interval in early breast cancer | 0.3% | Novartis AG — Kisqali FDA Review (NDA/BLA 209092, 2026), p.16 |
Source documents
- Novartis AG — Kisqali FDA Review (NDA/BLA 209092, 2026) (2026)
- Novartis AG — Kisqali FDA Summary Review (NDA/BLA 209092, 2024) (2024)
- NOVARTIS — Kisqali FDA Review (NDA/BLA 209092, 2019) (2019)
- Novartis AG — Kisqali EMA EPAR public assessment report (EMEA/H/C/004213, 2017) (2017)
- Novartis AG — Kisqali EMA EPAR variation assessment report (EMEA/H/C/004213, 2017) (2017)
Compared with
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.