NICE turns down Astellas’ Xtandi in prostate cancer

pharmafile | April 8, 2019 | News story | Research and Development, Sales and Marketing Astellas, Cancer, NHS, NICE, UK, pharma, prostate cancer 

Astellas’ Xtandi (enzalutamide) has been rejected by UK medicines watchdog NICE for use on the NHS as a therapy for prostate cancer, it has emerged, meaning patients may need to wait until a later stage of their disease in order to access the drug on the health service.  

Xtandi was assessed in a study of 1,401 participants, with 933 patients with non-metastatic prostate cancer taking Astellas’ testosterone-blocking drug, with the rest taking placebo. It was found that the therapy improved progression-free survival by 36.6 months on average versus 14.7 months with placebo.

Despite these promising findings, NICE judged that these data are not mature enough to prove the drug’s efficacy conclusively, arguing that the trial has not run for long enough to adequately show its ability to boost survival rates. Because of this lack of data, NICE could not consider the treatment a cost-effective use of NHS resources, and noted that earlier use of the drug could limit future options for patients.

“This decision may be disappointing for people affected by prostate cancer. Clinical trial evidence suggested this drug could give patients more time before the disease begins spreading to other parts of the body,” commented Emlyn Samuel, Head of Policy Development at Cancer Research UK. “NICE have concluded on the basis of the available evidence that the drug may offer patients greater benefit in the long-run if it is saved for use at a later stage of the disease – where it is already approved for NHS patients.”

Matt Fellows

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