Erleada(Apalutamide)
Oncology· 828 cited findings· 1 source document
Company: Johnson & Johnson →
What the regulatory reviews say
Erleada (apalutamide) is a drug approved under NDA 210951 with Priority review status. The application was submitted on October 09, 2017, received on October 10, 2017, and had a PDUFA Goal Date of April 10, 2018, with a Review Completion Date of February 13, 2018.
In efficacy studies, apalutamide demonstrated a median Metastasis Free Survival (MFS) of 40.51 months, compared to 16.20 months in the placebo arm, with a Hazard Ratio of 0.28 (p-value <0.0001). The median Time to Metastasis (TTM) for apalutamide was 40.51 months, versus 16.59 months for placebo, with a Hazard Ratio of 0.27 (p-value <0.0001). Time to Symptomatic Progression events were 60 in the apalutamide arm and 59 in the placebo arm, with a Hazard Ratio of 0.45 (p-value <0.0001).
Safety findings included a 7.7% death rate in the apalutamide arm. Hypertension was observed in 25% of patients (all-grade) and 14% (Grade 3-4). The incidence of ischemic heart disease was 3.7%.
Key figures — cited to the source page
| Median Metastasis Free Survival (MFS) in apalutamide arm | 40.51 months | Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2, p.18 |
| Median Metastasis Free Survival (MFS) in placebo arm | 16.20 months | Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2, p.18 |
| Metastasis Free Survival (MFS) Hazard Ratio | 0.28 | Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2, p.18 |
| Metastasis Free Survival (MFS) p-value | <0.0001 | Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2, p.18 |
| Deaths in apalutamide arm | 7.7 % | Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2, p.18 |
| hypertension (all-grade) | 25 % | Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2, p.141 |
| Application Number | 210951 | Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2, p.4 |
| Review Completion Date | February 13, 2018 | Johnson & Johnson — Erleada FDA Review (NDA210951, ORIG 1, 2, p.4 |
Source documents
Explore the full evidence
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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.