FDA Oncology Announcements

Second-generation nonsteroidal antiandrogen × Genitourinary × Clear all

10 Announcements

FDA approves darolutamide for metastatic castration-sensitive prostate cancer

Trial: ARASENS
Drugs: Nubeqa (darolutamide) · Second-generation nonsteroidal antiandrogen, docetaxel · Taxane
Condition: Genitourinary

FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

Drug: Xtandi (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer

Trial: TALAPRO-2
Drugs: Talzenna (talazoparib) · PARP inhibitor, enzalutamide · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer

Drugs: Nubeqa (darolutamide) · Second-generation nonsteroidal antiandrogen, docetaxel · Taxane
Condition: Genitourinary

FDA approves enzalutamide for metastatic castration-sensitive prostate cancer

Trial: ARCHES
Drug: XTANDI (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves apalutamide for metastatic castration-sensitive prostate cancer

Trial: TITAN
Drug: ERLEADA (apalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves darolutamide for non-metastatic castration-resistant prostate cancer

Trial: ARAMIS
Drug: NUBEQA (darolutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves enzalutamide for castration-resistant prostate cancer

Trial: PROSPER
Drug: XTANDI (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

FDA approves apalutamide for non-metastatic castration-resistant prostate cancer

Trial: SPARTAN
Drug: Erleada (apalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary

Enzalutamide (XTANDI Capsules)

Drug: XTANDI Capsules (enzalutamide) · Second-generation nonsteroidal antiandrogen
Condition: Genitourinary