Nubeqa(darolutamide)
Oncology· 1747 cited findings· 2 source documents
Company: Bayer Aktiengesellschaft
What the regulatory reviews say
Nubeqa (darolutamide) is a drug that received a Priority NDA application (NDA212099) from Bayer Aktiengesellschaft, submitted on February 26, 2019, and with a PDUFA Goal Date of August 26, 2019. The application was for darolutamide, with Nubeqa as the proposed trade name.
In efficacy studies, darolutamide demonstrated an estimated median Metastasis-Free Survival (MFS) of 40.4 months, compared to 18.4 months for placebo. The MFS Hazard Ratio was 0.380 (95% CI: 0.341, 0.500), with a p-value of <0.0001. A total of 255 patients experienced a PFS event. The Bayesian posterior mean of the stratified hazard ratio (non-informative prior) was 0.413, with a 95% HPD interval of 0.344 to 0.504. In the darolutamide arm, 22.6% of patients had baseline metastasis, while 18.1% of placebo patients had baseline metastasis.
Regarding safety, 52 (6%) darolutamide patients experienced dose reductions due to adverse events. Thrombocytopenia (any grade) was observed in 1.4% of patients in the placebo arm.
Key figures — cited to the source page
| Estimated median MFS (darolutamide) | 40.4 | Bayer Aktiengesellschaft — Nubeqa FDA Review (NDA212099, ORI, p.147 |
| Estimated median MFS (placebo) | 18.4 | Bayer Aktiengesellschaft — Nubeqa FDA Review (NDA212099, ORI, p.147 |
| PFS Hazard Ratio | 0.380 | Bayer Aktiengesellschaft — Nubeqa FDA Review (NDA212099, ORI, p.120 |
| p-value for MFS | <0.0001 | Bayer Aktiengesellschaft — Nubeqa FDA Review (NDA212099, ORI, p.147 |
| Dose reductions due to AEs (darolutamide) | 52 (6%) | Bayer Aktiengesellschaft — Nubeqa FDA Review (NDA212099, ORI, p.135 |
| Thrombocytopenia (any grade, placebo arm) | 1.4 | Bayer Aktiengesellschaft — Nubeqa EMA EPAR variation assessm, p.68 |
| Application Type | NDA | Bayer Aktiengesellschaft — Nubeqa FDA Review (NDA212099, ORI, p.2 |
| Priority or Standard | Priority | Bayer Aktiengesellschaft — Nubeqa FDA Review (NDA212099, ORI, p.2 |
Source documents
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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.