New Drug For Prostate Cancer Gets F.D.A. Nod (New York Times)

By ANDREW POLLACK
Published: August 31, 2012

The Food and Drug Administration approved a new life-prolonging drug
for men with late-stage prostate cancer on Friday, adding to an
increasingly crowded field.

The new drug, which will be called Xtandi, was developed by
Medivation, a small San Francisco pharmaceutical company, in
partnership with the Japanese firm Astellas Pharma.

In clinical trials, men who received the drug, which was previously
known as MDV3100, lived a median of 18.4 months, nearly five months
longer than the median of 13.6 months for those who received a
placebo.

While the approval was not a surprise, its timing was. The F.D.A.
approved the drug after only a three-month review, three months ahead
of the deadline in late November. This is fairly rare, although a
number of other cancer drugs have been approved at least a month ahead
of deadline in recent years.

“The need for additional treatment options for advanced prostate
cancer continues to be important,” Dr. Richard Pazdur, the director of
the agency’s cancer drug office, said in a statement.

Xtandi is one of several new prostate cancer drugs that have come to
market in the last two years after a long fallow period. While the new
drugs have been good for men with the disease, they could add billions
of dollars to the nation’s medical bills.

Xtandi will cost $7,450 a month, Medivation said. That is higher than
some analysts had expected.

Before 2004, the only drug shown to prolong the survival of men with
advanced prostate cancer was the chemotherapy drug docetaxel. Now
there are four others on the market — Jevtana from Sanofi, Provenge
from Dendreon, Zytiga from Johnson & Johnson and Xtandi, which is
known generically as enzalutamide.

Xtandi is expected to compete most directly with Zytiga. Both are
pills, while the other drugs are given intravenously. And both are
aimed at the same patient population — men whose cancer has spread
elsewhere in the body or recurred despite treatment aimed at
suppressing production of the hormone testosterone, which fuels
prostate cancer growth.

Both drugs are approved for men who have already tried docetaxel,
though both Medivation and Johnson & Johnson hope to eventually win
approval for their drugs to be used before docetaxel, a potentially
much larger market. Many patients would prefer to use the pills before
having to try chemotherapy.

Zytiga prolonged median survival by 3.9 months, as initially reported,
though Johnson & Johnson later updated that figure to 4.6 months.
Zytiga, which was approved in April 2011, had worldwide sales of $432
million in the first six months of this year.

Xtandi and Zytiga have not been compared head-to-head in a clinical
trial. But some analysts say Xtandi would have an edge because it does
not have to be given with prednisone, a steroid, to minimize side
effects, as Zytiga does.

Xtandi has its own side effects, however, the most worrisome being
seizures, which were suffered by about 1 percent of men taking it in
the clinical trial.

There are expected to be about 241,000 new cases of prostate cancer
this year in the United States and about 28,000 deaths.

Many men are treated with drugs like Lupron that, in effect, induce a
chemical castration, suppressing production of testosterone. But the
cancers can eventually become resistant to castration therapy.

Xtandi works by blocking the downstream effects of the action of
testosterone, rather than by turning off its production.

It is the first product to reach the market for Medivation. The
company previously developed an old Russian antihistamine as a
potential treatment for Alzheimer’s disease, signing a big partnership
with Pfizer. But that drug failed in late-stage clinical trials.

Shares of Medivation closed at $104.86 Friday, up nearly 8 percent.
The share price is about six times as high as it was before Medivation
announced the results of its clinical trial last November.
A version of this article appeared in print on September 1, 2012, on
page B3 of the New York edition with the headline: New Drug For
Prostate Cancer Gets F.D.A. Nod.