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Astellas’ Xtandi cancer drug rejected by NICE

England’s HTA questions the treatment’s efficacy and cost

Xtandi NICE has knocked back Astellas' new prostate cancer drug Xtandi (enzalutamide) because of the 'many uncertainties' in the treatment's data. 

The newly released draft guidance does not recommended Xtandi as a treatment for advanced prostate cancer. NICE said in a statement: “there are too many uncertainties associated with the evidence provided by drug manufacturer”.   

The drug is licensed to treat people with prostate cancer that has spread to other parts of the body and who have not yet had chemotherapy; and also in whom treatments to lower the amount of male sex hormones - which normally stop the cancer from growing and spreading - no longer work. 

Sir Andrew Dillon, NICE's chief executive, said: “The clinical trial results showed Xtandi can extend life when compared with placebo, but it was not clear for how long. 

“This was because there were uncertainties associated with way the company had carried out adjustments to take account of the effect on length of life of treatments used when Xtandi is no longer effective. 

“The Appraisal Committee was also concerned that the company had not adequately evaluated the uncertainties in its cost-effectiveness analyses."

Astellas said it was "disappointed" with the decision, but added that it was "hopeful that this draft decision will be overturned to give men for whom chemotherapy is not yet clinically indicated an additional much-needed treatment option".

The treatment is currently available under the Cancer Drugs Fund - a silo budget set up in 2010 and funds some new cancer medicines that have been rejected by NICE. 

Xtandi is already NICE-approved for men with metastatic hormone-relapsed prostate cancer, who have already had treatment with docetaxel-containing chemotherapy.

England's pricing watchdog also currently recommends the chemotherapy agent docetaxel for the treatment of hormone-refractory metastatic prostate cancer, and Janssen's Zytiga (abiraterone) for certain patients with metastatic prostate cancer who have already had treatment to reduce testosterone and have had docetaxel chemotherapy. 

Article by
Ben Adams

15th June 2015

From: Healthcare

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