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SMC ID Date Medicine Submission Type Indication
10/08/2026 lutetium (177Lu) vipivotide tetraxetan (Pluvicto) Non submission

Treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed on or after treatment with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

SMC2940 08/06/2026 darolutamide (Nubeqa) Non submission

Treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

SMC2942 08/06/2026 niraparib / abiraterone (Akeega) Non submission

With prednisone or prednisolone for the treatment of adult patients with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 gene mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

SMC2753 10/03/2025 talazoparib (Talzenna) Abbreviated

In combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

SMC2742 11/11/2024 enzalutamide (Xtandi) Non submission

As monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.

SMC2678 07/10/2024 relugolix (Orgovyx) Full

- For the treatment of adult patients with advanced hormone-sensitive prostate cancer.
- For the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
- As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

SMC2617 11/03/2024 olaparib (Lynparza) Full

In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

SMC2625 11/12/2023 degarelix (Firmagon) Abbreviated
  • for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy

  • as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer
SMC2604 09/10/2023 darolutamide (Nubeqa) Resubmission

Treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

SMC2517 09/10/2023 lutetium (177Lu) vipivotide tetraxetan (Pluvicto) Full

Treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

SMC2579 10/07/2023 apalutamide (Erleada) Abbreviated

In adult men for the treatment of non‑metastatic castration‑resistant prostate cancer (NM‑nmCRPC) who are at high risk of developing metastatic disease

SMC2472 12/09/2022 apalutamide (Erleada) Full

In adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

SMC2400 07/02/2022 enzalutamide (Xtandi) Full

For treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

SMC2366 11/10/2021 olaparib (Lynparza) Full

As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

SMC2297 09/11/2020 darolutamide (Nubeqa) Full

For the treatment of adult men with non-metastatic castration resistant prostate cancer who are at high risk of developing metastatic disease.

SMC2215 13/01/2020 abiraterone acetate (Zytiga) Full

with prednisolone for the treatment of adult men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT)

SMC2195 07/10/2019 enzalutamide (Xtandi) Full

For the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). High-risk is defined as prostate specific antigen (PSA) doubling time (PSADT) ≤10 months and PSA ≥2 ng/mL.

735/11 12/12/2016 cabazitaxel (Jevtana) Resubmission Cabazitaxel in combination with prednisone or prednisolone is indicated for the treatment of adult patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
1066/15 07/03/2016 enzalutamide (Xtandi) IRP Treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
873/13 12/10/2015 abiraterone (Zytiga) IRP abiraterone acetate is indicated with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
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