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Trial results spark fresh debate over prostate cancer drug access

Trial results described as a “milestone” in prostate cancer treatment are set to spark a fresh row over NHS access to new drugs.

Trial results to spark drug debate

Enzalutamide, a pill which blocks molecular signals driving prostate cancer, was shown to improve survival by almost 30% in men who have not yet undergone chemotherapy.

It also delayed the progression of advanced cancers that have ceased to respond to other treatments by 80%.

The news, broken at the American Society of Clinical Oncology meeting in San Francisco, prompted immediate demands for another U-turn from the NHS rationing watchdog.

Last week the National Institute for Health and Care Excellence (NICE), which vets the cost effectiveness of NHS treatments, provoked anger by revising its draft guidance on enzalutamide.

It ruled that men in England should not qualify for the medicine if they have previously been treated with another new-generation prostate cancer drug, abiraterone, but now Nice is under pressure to review its guidance again.

A NICE spokeswoman said its newly revised draft guidance would allow enzalutamide to be made available to a greater number of men as it removes the restriction that it can be offered to those who have undergone only one round of docetaxel-containing chemotherapy. She said it is now also recommended for patients who have had additional chemotherapy treatment.

She said NICE was currently unable to recommend the use of enzalutamide after treatment with abiraterone as there was no evidence to suggest this was an effective course of treatment.

“In the trial data provided by the manufacturer of enzalutamide none of the patients had received previous treatment with abiraterone, therefore the committee was not able to draw any conclusions about the effectiveness of enzalutamide after previous abiraterone treatment, and this is reflected in the recommendations,” she said. “We would welcome any additional data the manufacturer of enzalutamide can provide.”

The spokeswoman added: “It’s also important to bear in mind that whilst in current clinical practice enzalutamide can be accessed via the cancer drugs fund, the cancer drugs fund does not fund it following abiraterone as there is no evidence on the effectiveness of this sequential treatment.”

Abiraterone has already been approved for pre-chemo use in the US. The Food and Drugs Administration (FDA) took the decision in December 2012 in light of positive trial results showing a doubling of time to detectable tumour progression.

The new findings from the international Phase III “Prevail” trial are even more striking, showing improved survival as well as reduced disease progression in men treated with enzalutamide before chemotherapy.

Two prostate cancer charities are calling on NICE to change its “post-chemo” policy on the new drugs, which both block hormonal signals driving the disease.

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