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SMC ID Date Medicine Submission Type Indication
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.
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.
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.
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.
911/13 11/11/2013 enzalutamide (Xtandi) Full Treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy.

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