U.K.'s NICE throws Astellas a bone on Xtandi--or does it?

NICE's Carole Longson

First it was good news, then it was bad news, and now it's good news again for Astellas' prostate cancer treatment Xtandi (enzalutamide) and its recommendation from the U.K.'s National Institute for Health and Care Excellence (NICE). At least it appears that way.

In final guidance, the cost-effectiveness gatekeeper has nixed a proposed limitation on use of the drug for patients who have already been treated with a Johnson & Johnson ($JNJ) competitor. But whether it will actually endorse Xtandi in that patient population remains to be seen.

As PMLiVE reports, the watchdog has done away with a January guidance revision that ruled out Xtandi for patients who had taken J&J's hot-selling rival, Zytiga (abiraterone). NICE made the switch after the Japanese drugmaker provided new observational data suggesting that some patients may benefit from Xtandi after Zytiga use.

"We believe that all appropriate patients who can benefit should have access to enzalutamide on the NHS, which will allow clinicians to make the best treatment decisions for their patients," Dr. Alan McDougall, Astellas' medical director, told PharmaTimes.

That doesn't mean NICE is all for Xtandi use in former Zytiga patients, however; on the contrary, NICE said in a statement seen by PMLiVE that there were "too many uncertainties in the evidence" to endorse it, adding that its committee deemed it impossible "at this stage to make a recommendation on the clinical and cost-effectiveness of enzalutamide when given after abiraterone."

Indeed, some are skeptical that the revision provides any meaningful change--including Owen Sharp, the CEO of nonprofit Prostate Cancer UK. "If it transpires in reality that this is a de facto restriction thinly veiled by complex prose, we will be holding relevant parties to account," he told PMLiVE.

Neither Xtandi nor Zytiga is exactly hard up for sales. Both drugs--revolutionary therapies that hit the market in 2011 and 2012, with Zytiga getting the head start--put up big numbers last year. Zytiga raked in $1.7 billion in 2013 sales and Xtandi posted $739 million in the first half alone. Despite Zytiga's first-to-market advantage, analysts have tabbed Astellas' med to eventually overtake it.

In the meantime, Astellas will do its best to convince NICE of Xtandi's worth; the director of NICE's health technology evaluation center, Carole Longson, told PT Astellas is collecting data on the use of its drug after Zytiga.

"We look forward to seeing the results of the ongoing trials," she said.

- see the story from PMLiVE
- get more from PharmaTimes

Special Reports: Top 15 Drug Launch Superstars - Xtandi - Zytiga | The 25 most influential people in biopharma today - 2013 - Carole Longson - NICE

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Astellas' prostate-cancer prodigy Xtandi shines as pre-chemo treatment
NICE panel likes Astellas' cancer treatment Xtandi
Astellas forecasts big sales growth as prostate drug catches hold
Zytiga, Xtandi will help pump prostate cancer market to $9.1B
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