NICE recommends Xtandi
pharmafile | May 9, 2014 | News story | Sales and Marketing | Astellas, NICE, Xtandi, abiraterone, prostate
NICE has reiterated that Astellas Pharma’s Xtandi should be used to treat NHS prostate cancer patients – but has removed the restrictions which the watchdog previously placed on its use.
The new final draft guidance says men with hormone-relapsed prostate cancer that has spread to other parts of the body can access both abiraterone and Xtandi (enzalutamide) after receiving docetaxel chemotherapy, thus giving them a few more months of life.
Astellas had been ‘surprised and disappointed’ that in previous guidance NICE said Xtandi should only be open to patients who have not received abiraterone – and other stakeholders were equally unimpressed.
“We are very pleased that NICE has listened to the concerns we and others have raised, and dropped a controversial restriction on the use of enzalutamide from its draft guidance,” says Professor Alan Ashworth, chief executive of the Institute of Cancer Research.
“This restriction would have prevented men with advanced prostate cancer from accessing enzalutamide after receiving another life-extending drug, abiraterone,” he adds.
Astellas gave NICE some new studies looking at how well Xtandi works in patients who received previous treatment with abiraterone, and demonstrated that “a proportion of patients may benefit from Xtandi after abiraterone.
“During consultation on the draft recommendations for using enzalutamide, we received a number of responses, including data and comments from the manufacturer of the drug, professional organisations and patient groups,” explains Professor Carole Longson, NICE centre for health technology evaluation director.
“Due to this additional information we now know that, at the moment, evidence on the effectiveness of enzalutamide when given after abiraterone is too uncertain to make a definitive evidence-based recommendation, so we have not done so,” she adds.
“We know that the manufacturer is currently collecting data on the use of enzalutamide after abiraterone and we look forward to seeing the results of the ongoing trials,” Longson concludes.
Developed with Medivation, Xtandi was approved in Europe last June and is tipped by analysts to be a blockbuster, earning as much as $2 billion in peak sales.
This figure is predicted, in large part, because of its proven ability to extend life by shrinking and killing cancer cells: in the Phase III AFFIRM trial, patients taking the drug had a median survival time of 18.4 months – an increase of 4.8 months on those in the placebo arm.
As well as being effective, the oral drug is also convenient, allowing patients to administer it at home – it can also be taken on a full stomach.
Adam Hill
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