Prostate Cancer: Latest Developments

Short summaries of recently published approvals, licensing and reimbursement regulations in Turkey, and notable studies in prostate cancer. For general information about the disease, see the Prostate Cancer page.

• • FDA Approval
  • Prostate Cancer
  • 26 October 2026

  Talazoparib with enzalutamide receives FDA approval in hormone-sensitive metastatic prostate cancer with HRR gene mutations

  The FDA approved the PARP inhibitor talazoparib in combination with enzalutamide for adults with metastatic prostate cancer that is androgen pathway modulation-naïve or -sensitive and carries homologous recombination repair (HRR) gene mutations. Mutations are detected with an FDA-authorised test on tumour tissue or blood (circulating tumour DNA). In the TALAPRO-3 trial, 599 patients were randomised to enzalutamide plus either talazoparib or placebo; all patients continued androgen deprivation therapy. The hazard ratio for radiographic progression-free survival was 0.48; the median was not reached in the talazoparib arm and was 45.8 months in the placebo arm. Overall survival data are still immature. The label includes warnings on bone marrow suppression, myelodysplastic syndrome/acute myeloid leukaemia and embryo-foetal toxicity. The combination was previously approved (June 2023) for HRR-mutated metastatic castration-resistant prostate cancer; the new approval moves it to an earlier stage of the disease. Treatment decisions should take into account both the genetic test result and the patient’s overall condition.

  Status in Turkey: Talazoparib is licensed in Turkey (TİTCK list of licensed products, 16.10.2026); however, the prostate cancer indication in the approved KÜB (06.05.2026) is limited, in combination with enzalutamide, to BRCA1/2-mutated metastatic castration-resistant disease. The licence for this new use in hormone-sensitive disease in Turkey could not be verified. The SGK list of reimbursed medicines (EK-4/A, as of 23.10.2026) contains no product with talazoparib; reimbursement for this new use could not be verified.

  • Source:
  • FDA announcement (26 October 2026)
  • FDA announcement (June 2023, castration-resistant disease)
• • FDA Approval
  • Prostate Cancer
  • 31 July 2026

  Lutetium-177 PSMA therapy receives FDA approval in PSMA-positive hormone-sensitive metastatic prostate cancer

  The FDA approved the radioligand therapy lutetium Lu 177 vipivotide tetraxetan, together with an androgen receptor pathway inhibitor (ARPI), for use in adults with PSMA-positive, hormone-sensitive metastatic prostate cancer. Patients are selected by PSMA PET imaging. In the PSMAddition trial, 1144 patients were randomised to six doses of radioligand therapy given every six weeks plus an ARPI, or an ARPI alone; all patients also received hormone-suppressing treatment. The hazard ratio for radiographic progression-free survival was 0.72; median values were not reached in either arm. Overall survival data are not yet mature. This drug had previously been approved in castration-resistant metastatic prostate cancer; the new approval moves the treatment to an earlier stage of the disease.

  Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with lutetium Lu 177 vipivotide tetraxetan.

  • Source:
  • FDA announcement (31 July 2026)
• • FDA Approval
  • Prostate Cancer
  • 12 June 2026

  Capivasertib receives FDA approval in hormone-sensitive metastatic prostate cancer with PTEN deficiency

  The FDA approved capivasertib, an AKT inhibitor, together with abiraterone and prednisone for adults with hormone-sensitive metastatic prostate cancer with PTEN deficiency. PTEN deficiency is determined by an immunohistochemistry test on tumour tissue, and this test was approved as a companion diagnostic. In the CAPItello-281 trial, 1012 newly diagnosed patients were randomised to receive capivasertib or placebo in addition to abiraterone. Median radiographic progression-free survival was 33.2 versus 25.7 months (hazard ratio 0.81). Overall survival data were not mature at the time of analysis. Warnings include elevated blood glucose, diarrhoea and skin rash; monitoring blood glucose during treatment is important.

  Status in Turkey: Capivasertib was licensed in Turkey on 31.07.2026; however, the indication in the KÜB is limited to breast cancer. The licence and reimbursement status in prostate cancer in Turkey has not yet been clarified.

  • Source:
  • FDA announcement (12 June 2026)
• • SGK Reimbursement
  • Prostate Cancer
  • 23 May 2026

  SGK expanded the reimbursement scope for abiraterone and darolutamide in prostate cancer

  With the SUT amendment published in the Official Gazette of 23 May 2026 (no. 33262), two new reimbursement conditions were defined in prostate cancer. Abiraterone, provided it has an indication approved by the Ministry of Health, will be reimbursed in non-metastatic high-risk prostate cancer unsuitable for surgery, together with radiotherapy and androgen deprivation therapy (ADT), for up to 2 years. High risk is defined by the presence of at least two of the following: lymph node involvement or clinical T3–T4 stage, a Gleason score of 8–10, and a PSA above 40 ng/ml. Darolutamide will be reimbursed when used with ADT in hormone-sensitive metastatic prostate cancer without visceral (internal organ) metastasis. The regulation entered into force 5 working days after publication.

  Status in Turkey: Products containing darolutamide and abiraterone are on the SGK EK-4/A list.

  • Source:
  • Official Gazette, 23.05.2026, no. 33262 (SUT amendment)

There are no developments to show for this selection. You can change the filters and try again.

The news on this page is for general information only; it is not a diagnosis or treatment recommendation. Whether a treatment is suitable for you is decided together with your physician after assessing the characteristics of your disease.