NICE shoots down AstraZeneca's Faslodex, citing dearth of survival data

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AstraZeneca's Faslodex was also rejected by NICE in 2011 in a different indication.

It was a good week for AstraZeneca’s Faslodex—until Friday.

England’s National Institute of Health and Care Excellence (NICE) released draft guidance recommending against use of the elderly breast cancer med as an option for delaying growth of estrogen-receptor-positive breast cancer that has spread to other parts of the body in patients who haven’t yet been treated with hormonal therapy.

The reason? Current evidence doesn’t prove that it extends survival more than less expensive therapies that are already out there, NICE said. And while Faslodex (fulvestrant) has showed it can stall cancer growth by about three months more than aromatase inhibitors can, the cost watchdog said it’s too early to say whether that actually translates into an overall survival boost.

NICE has to ensure that the NHS provides treatments that bring benefits which are value for money. As fulvestrant has not been shown to be cost effective, we can’t justify diverting NHS funds from other areas of healthcare in order to fund its use,” Carole Longson, director of NICE’s center for health technology evaluation, said in a statement.

It’s not the first time Faslodex has gotten the cold shoulder from the cost-effectiveness gatekeepers. In 2011, the body published guidance spurning Faslodex as a treatment for some patients who had relapsed on or after adjuvant anti-estrogen therapy.

This time around, though, AstraZeneca still has time to change some minds at NICEand discounts have been known to do the trick. NICE’s appraisal committee will meet again on Oct. 4, and between now and then, the company may be able to win backing for the estimated 1,200 patients in England who would be eligible for therapy.

“AstraZeneca believes fulvestrant is a significant therapy option for this group of patients,” the pharma giant said in a statement, noting that it was “disappointed” and would “continue the ongoing dialogue with NICE to enable this treatment option to be made available for this important group of patients.”

RELATED: AstraZeneca oldie Faslodex nets another breast cancer approval

Meanwhile, on the other side of the pond, the med got a boost Monday. After showing it could top fellow AZ med Arimidex at delaying time until disease progression, Faslodex netted an indication for solo use in HR+, HER2- breast cancer patients who haven’t been previously treated with endocrine therapy. It’s the second FDA green light in two years for the product, which first debuted in 2002; last year, it snagged a thumbs up in tandem with Pfizer blockbuster Ibrance.