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NICE backs Xtandi but turns down Zytiga

Astellas and Medivation's pre-chemotherapy prostate cancer drug receives support

Astellas XtandiUK cost-effectiveness agency NICE has given a boost to Astellas and Medivation's Xtandi, backing its use in pre-chemotherapy prostate cancer at the end of last week.

NICE said in draft guidance that it supported the use of Xtandi (enzalutamide) in patients whose prostate cancer has spread after the failure of first-line therapy but for whom chemotherapy is not yet necessary.

Astellas and Medivation's drug (pictured left) can delay the need for chemotherapy, is well-tolerated and improves survival, said NICE, and is an appropriate use of NHS resources, with an incremental cost-effectiveness ration of £34,500 compared to best supportive care.

The agency was less impressed with Johnson & Johnson's Zytiga (abiraterone acetate) however, turning it down as an option for pre-chemo use by the NHS in England and Wales and handing an important advantage to Xtandi as it tries to claw market share from its rival.

While also acknowledging that Zytiga is well-tolerated and delays the need for chemotherapy, NICE's appraisal committee said it was unsure about the drug's long-term benefits and calculated its incremental cost-effectiveness ration at between £35,500 and £59,000.

Xtandi recently passed the $3bn sales mark since its launch in 2012, helped by approval in the pre-chemo setting last year, as well as data from the STRIVE trial which revealed a benefit for Astellas and Medivation's drug compared to bicalutamide, the standard therapy for castration-resistant prostate cancer (CRPC).

While the companies have yet to secure approval for labelling that explicitly notes the head-to-head advantage against bicalutamide, the data is thought to be encouraging strong uptake of the drug.

Zytiga is one of J&J's top-selling drugs, adding $1.65bn to the group's top-line in the first nine months of the year, although its growth rate has started to dip in the face of competition, particularly in Europe. In the same period Astellas reported $1.3bn in sales.

"It is very welcome that NICE has decided that men with prostate cancer can access the drug enzalutamide without having to go through chemotherapy first," said Prof Paul Workman, chief executive of the Institute of Cancer Research (ICR).

However, he said the decision not to back Zytiga "is a real blow", particularly as the drug has been made available to men with prostate cancer in Scotland on the NHS.

Article by
Phil Taylor

14th December 2015

From: Regulatory



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