Talazoparib plus enzalutamide [TAL2]

For the treatment of metastatic hormone- relapsed (castrate-resistant) prostate cancer in patients who are treatment naïve to androgen receptor inhibitors and in whom chemotherapy is not yet clinically indicated or appropriate where the following criteria have been met:

1. This application for talazoparib plus enzalutamide is being made by and the first cycle of systemic anti-cancer therapy with talazoparib plus enzalutamide will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient either has a proven histological or cytological diagnosis of adenocarcinoma of the prostate or has presented with a clinical picture consistent with metastatic prostate cancer with both widespread bone metastases typical of prostate cancer and a serum PSA of at least 50ng/ml.
3. The patient has progressive hormone-relapsed (castrate-resistant) disease.
4. The patient has not been treated with chemotherapy for the hormone-relapsed (castrate-resistant) indication and that for this same hormone-relapsed (castrate-resistant) indication chemotherapy is either not yet clinically indicated or is inappropriate (contraindicated or declined by the patient).

Note

Note: chemotherapy given for hormone-sensitive disease earlier in the treatment pathway does not exclude patients from potential access to talazoparib plus enzalutamide.

5. The patient has pre existing clinical conditions that preclude the use of abiraterone plus prednisolone (given with olaparib) OR the patient commenced abiraterone (with olaparib) in this same indication, and that combination had to be discontinued due to lack of tolerance (despite dose reductions being instigated) in the absence of any signs of disease progression. Please mark below which scenario applies to this patient:

• the patient has pre existing clinical conditions that preclude the use of abiraterone plus prednisolone (given with olaparib) OR
• the patient commenced abiraterone (with olaparib) in this same indication, and that combination had to be discontinued due to lack of tolerance (despite dose reductions being instigated) in the absence of any signs of disease progression.

6. The patient has not previously received any therapy with an androgen receptor inhibitor such as enzalutamide, abiraterone, apalutamide or darolutamide at any place in the prostate cancer treatment pathway except in the case of patients who received androgen receptor inhibitor therapy for hormone-sensitive disease and stopped this treatment more than 12 months prior to this application without PSA progression or evidence of clinical or radiological progressive disease at the time such androgen receptor inhibitor therapy was discontinued OR the patient commenced abiraterone (with olaparib) in this same indication, and that combination had to be discontinued due to lack of tolerance (despite dose reductions being instigated) in the absence of any signs of disease progression Please mark below which scenario applies to this patient:

• the patient has not previously received any therapy with an androgen receptor inhibitor such as enzalutamide, abiraterone, apalutamide or darolutamide at any place in the prostate cancer treatment pathway OR
• the patient received androgen receptor inhibitor therapy for hormone-sensitive disease and stopped this treatment more than 12 months prior to this application without PSA progression or evidence of clinical or radiological progressive disease at the time such androgen receptor inhibitor therapy was discontinued OR
• the patient commenced abiraterone (with olaparib) in this same indication, and this combination had to be discontinued due to lack of tolerance (despite dose reductions being instigated) in the absence of any sign of disease progression

Note

Note: previously treated with previous androgen receptor therapy who do not fulfil the exceptions above are NOT eligible treatment plus patients inhibitor for with olaparib olaparib had to be 7. The patient has not received any previous PARP inhibitor therapy, unless the patient commenced (with abiraterone) in this same indication, and that combination discontinued due to lack of tolerance (despite dose reductions being instigated) in the absence of any signs of disease progression.

8. The patient has an ECOG performance score of 0 or 1.
9. Talazoparib is only to be given in combination with enzalutamide.

Note

Note: talazoparib cannot be given in combination with abiraterone or any other androgen receptor inhibitor. Note: it is expected that treatment with LHRH agonists/antagonists will continue unless the patient has undergone surgical castration.

10. Talazoparib and enzalutamide are to be continued until disease progression or the development of unacceptable toxicity or patient choice to discontinue treatment, whichever is the sooner.
11. When a treatment break of more than 6 weeks beyond the expected 4-week cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment, which MUST be approved before treatment is recommenced.
12. Talazoparib and enzalutamide will otherwise be used as set out in their respective Summaries of Product Characteristics (SPCs).

CDF funded From: 23 January 2026

Additional information

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The data on this page was produced using version 1.385 of the CDF list, downloaded from NHS England’s website on 27 January 2026 at 22:25.

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