Enzalutamide

The UK health watchdog has changed its stance on Pfizer’s Talzenna, now recommending the once-daily drug for NHS use. Image credit: NMK-Studio via Shutterstock.com. The UK’s National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Talzenna (talazoparib) in a step forward for patients in England with prostate cancer. Following the NICE’s decision on 23 January, the once-daily pill will be available to patients with metastatic prostate cancer through the National Health Service (NHS) – adding to its previous recommendation for the drug’s use in metastatic breast cancer . NICE is recommending Talzenna’s use when taken alongside hormonal therapy Xtandi (enzalutamide). Talzenna-Xtandi is specifically indicated for patients with prostate cancer who are not eligible to receive treatment with standard of care (SoC) hormonal therapy plus corticosteroid combinations such as abiraterone-prednisolone. This recommendation marks a shift in stance for NICE, which provisionally stated last year it would not support the drug’s use in prostate cancer. However, the UK health watchdog has since reconsidered its position based on the outcome of a public consultation. Talzenna is a poly-ADP ribose polymerase (PARP) inhibitor that acts by blocking the repair of single-strand breaks in cancer cells, causing genomic instability and cancer cell death. According to Helen Knight, director of medicines evaluation at NICE, the Talzenna recommendation is an “important step forward” for patients with prostate cancer – particularly for those who are unable to receive treatment with chemotherapy or other commonly used medicines. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Knight also touted Talzenna-Xtandi’s at-home administration, which provides a “convenient and flexible” treatment option for patients. The Institute of Cancer Research welcomed the news, stating: “The recommendation marks an important step forward in giving people more treatment options – especially those who cannot undergo chemotherapy. Patients can take the once-daily pill at home, offering convenience and flexibility.” Talzenna is one of three drugs for prostate cancer treatment to recently secure NICE approval, with Bayer and Orion’s oral androgen receptor therapy Nubeqa (darolutamide) and Zytiga (abiraterone) plus its generics being recommended for NHS use in October 2025. The combination therapy first gained US regulatory approval alongside androgen receptor inhibitor Xtandi in prostate cancer in 2023 while the European Commission (EC) approved Talzenna-Xtandi in 2024. Talzenna faces competition in prostate cancer market While the NICE’s decision is a win for Pfizer, Talzenna is part of a competitive metastatic prostate cancer market. This includes AstraZeneca’s PARP inhibitor Lynparza (olaparib), which GlobalData estimates will bring in global sales of $3.5bn at its sales peak across all indications in 2027. However, the drug’s market exclusivity expires in 2027, leaving it vulnerable to generic competition. GSK’s PARP inhibitor Zejula (niraparib) is also a strong market contender, with GlobalData estimating that the drug will generate $791m in global sales at its 2027 peak. Pharma & Schweiz’s Rubraca (rucaparib) also cemented itself in the US market recently, as the PARP inhibitor gained full approval from the US Food and Drug Administration (FDA) in late December 2025. Pharma & Schweiz previously acquired the drug from Clovis Oncology for up to $135m as the latter company looked to sell its assets amid Chapter 11 bankruptcy. GlobalData forecasts that Rubraca will make $139m at its 2029 sales peak in prostate cancer. GlobalData, parent company of Pharmaceutical Technology , forecasts that Talzenna will make global sales of $636m in 2031.

The Institute of Cancer Research, London, welcomes the decision by the National Institute for Health and Care Excellence (NICE) to recommend the targeted drug talazoparib (trade name Talzenna), in combination with enzalutamide, for adults with prostate cancer that has spread. The judgement makes this new drug combination available for around 2,400 patients in England who cannot take standard treatments and for whom chemotherapy is not suitable. The recommendation marks an important step forward in giving people more treatment options – especially those who cannot undergo chemotherapy. The once-daily pill can be taken at home, offering convenience and flexibility for patients. Professor Johann de Bono, Regius Professor of Cancer Research at The Institute of Cancer Research (ICR) and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, led the first-in-human talazoparib trial as well as the phase II TALAPRO-1 trial, which showed that talazoparib could kill prostate cancer cells and prevent its growth. The trial demonstrated the effectiveness and tolerability of the drug for the first time in prostate cancer. The follow-up phase III trial, TALAPRO-2, tested the drug in combination with enzalutamide, with results providing the basis for the NICE recommendation. Talazoparib is a PARP inhibitor – it blocks an enzyme that repairs damaged DNA in certain cancer cells. Cancer cells with DNA repair gene faults – such as BRCA, ATM or PALB2 – already have a defective DNA repair system. By using a drug to block PARP, which helps repair DNA when it is damaged, cancer cells are unable to repair themselves. Twenty years ago, a team of ICR researchers first discovered that PARP inhibitors could be used to target BRCA-mutated cancers. Together with The Royal Marsden, researchers at the ICR including Professor Johann de Bono trialled a PARP inhibitor called olaparib in patients with breast and prostate cancer containing DNA repair gene faults. A team of ICR researchers, led by Professor Alan Ashworth and Professor Chris Lord in the Breast Cancer Now Toby Robins Research Centre, first described talazoparib and explained how it works in 2013. Researchers at the ICR then led the first trials of the drug in humans, in 2017. The drug now joins olaparib as one of the first genetically targeted treatments for prostate cancer. As a targeted therapy, it is a much kinder option for patients than chemotherapy. Professor Johann de Bono, Regius Professor of Cancer Research at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “There is an urgent need for effective treatment options after hormonal therapies have stopped working against advanced prostate cancer. The approval of talazoparib will provide another treatment option for these men. The pill can be taken at home, and it comes without many of the side effects of chemotherapy. “In our TALAPRO-1 trial, we showed that talazoparib – a type of PARP inhibitor – kills prostate cancer cells and puts this into remission, especially in men whose tumours have faults in DNA repair genes such as BRCA mutations. The follow-up trial, TALAPRO-2, provided the basis of today’s decision.”