From Elie Dolgin of Nature magazine covers the news:

Men with advanced prostate cancer now have another treatment option, thanks to the approval today by the US Food and Drug Administration (FDA) of a pill that blocks androgen-receptor signaling and prolongs patient survival.

“To see activity in a post-hormone treated, post-chemotherapy treated prostate cancer population with a drug that doesn’t have myelosuppression [a decrease in blood cell production] and does has a very favorable safety profile is extremely exciting,” says Howard Scher, a prostate cancer specialist at the Memorial Sloan-KetteringCancer Center in New York. “My patient who got the drug in July 2007 is still on it. I have chills actually. It’s pretty amazing.”

The newly approved agent—Xtandi (enzalutamide), developed by San Francisco’s Medivation and Japan’s Astellas Pharma—works by plugging up the receptors that bind androgens, including testosterone, to prevent those male hormones from fueling the growth of prostate cancer cells. In a phase 3 clinical trial involving around 1,200 men with prostate cancer that had spread despite prior chemo- and hormone-therapy, an international team led by Scher found that participants taking Xtandi lived a median of 18.4 months, compared to 13.6 months for those who received a placebo. The drug also significantly lowered levels of prostate-specific antigen and boosted the time of progression-free survival, with only minimal side effects of fatigue, diarrhea and rare seizures. The results were reported earlier this month in the New England Journal of Medicine.

Read the complete coverage here.