FDA Approves Three New Targeted Therapies for Advanced Prostate Cancer

The U.S. Food and Drug Administration has approved three new targeted therapies for different stages and molecular subtypes of advanced prostate cancer in recent weeks. The approvals provide precision medicine options for patients with specific genetic mutations who have limited treatment alternatives.

The FDA approved Truqap (capivasertib) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naive or -sensitive prostate cancer whose tumors have PTEN deficiency. PTEN deficiency affects about one in four of the roughly 35,000 U.S. patients diagnosed annually with this subtype. A companion diagnostic test was also approved to identify PTEN deficiency. In a clinical study, adding Truqap to standard hormone therapy reduced the risk of cancer progression or death compared with placebo. Median time without cancer worsening was 33.2 months with the combination versus 25.7 months with abiraterone alone, corresponding to a 19% lower risk of progression or death. Common side effects included rash, high blood sugar, diarrhea, and tiredness.

On December 17, 2025, the FDA granted regular approval to rucaparib (Rubraca) for adults with BRCA mutation-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy. Rucaparib had received accelerated approval in 2020 for a similar indication. The regular approval was based on the TRITON3 trial, which enrolled 405 patients with metastatic castration-resistant disease. In patients with BRCA mutations, treatment with rucaparib significantly improved radiographic progression-free survival compared to physician's choice of alternative therapy. Median progression-free survival was 11.2 months with rucaparib versus 6.4 months with comparator treatments. Overall survival results were not statistically significant. The prescribing information includes warnings for myelodysplastic syndrome/acute myeloid leukemia and embryo-fetal toxicity.

On December 12, 2025, the FDA approved Akeega (niraparib and abiraterone acetate dual-action tablet) plus prednisone for patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. This marks the first precision therapy approved for this earlier stage of disease. The approval was based on the Phase 3 AMPLITUDE trial, which enrolled 696 participants. Treatment with Akeega plus prednisone and androgen deprivation therapy significantly reduced the risk of radiographic progression or death by 54% compared to placebo plus standard hormone therapy. The combination also prolonged time to symptomatic progression by 59%. The safety profile was consistent with known profiles of the individual medications.