NICE Draft Guidance Recommends Astellas’ Xtandi for Prostate Cancer

NICE Draft Guidance Recommends Astellas' Xtandi for Prostate CancerRegulatory body, the National Institute for Health and Care Excellence (NICE), have opened a second consultation on the use of Astellas’ Xtandi in patients with prostate cancer, after widening the drug’s target population.

The regulatory affairs agency issued new draft guidance this morning recommending the use of Xtandi in adult patients with hormone relapsed metastatic prostate cancer.

Xtandi has a different mechanism of action from other anti-androgens on the market; it works by blocking the binding of androgens to androgen receptors, prevents activated androgen receptors from migrating to the nucleus, and blocks the interaction of the activated androgen receptor with DNA in the nucleus to help prevent the spread of the disease.

NICE is currently advising that the drug should be used only when a patient’s disease has progressed during or after a docetaxel-containing chemotherapy regimen, and they have not been treated with Johnson’s & Johnson’s prostate cancer drug Zytiga (abiraterone).

NICE explained that the reason for the restriction was because Astellas did not provide any data from clinical studies involving patients who had received prior treatment with Zytiga.

“Therefore the Committee was not able to draw any conclusions about the effectiveness of enzalutamide after previous abiraterone treatment,” said the regulatory cost-effectiveness body.

This guidance is different from the initial draft guidance for Xtandi published in October, which stated that the drug should only be used where the prostate cancer has progressed during or after one docetaxel-containing chemotherapy, and not any number of such regimens, a limitation which has now been removed, resulting in a widening of the drug’s potential scope.

Xtandi more convenient

Whilst both Xtandi and Zytiga are oral treatments, only Xtandi can be taken on a full stomach, making it more convenient to take.  In addition, the regulatory body was also informed that Xtandi can help control the cancer longer as there is no need to reduce the dose to prevent liver toxicity, as with Zytiga.

The cost regulator also specified that the endorsement is reliant on the continued provision of Xtandi at a confidential discount under a patient access scheme.

The Scottish Medicines Consortium (SMC) have already recommended the use of Xtandi on the NHS in Scotland last November.

Astella “surprised” by decision

In response to NICE’s decision, Astellas have said they are “surprised”, and noted that the decision will limit the decision-making ability of healthcare professionals in England and Wales.

Dr Alan McDougall, medical director at Astellas in the UK, commented: “Today’s announcement from NICE represents a major setback for many prostate cancer patients who would otherwise be eligible for treatment with enzalutamide according to the original draft guidance and licensed indication.”

The recommendation is now up for discussion before further draft guidance is issued by NICE.


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