TRIP

Novel Androgen Drug Gets 'Wow' in Advanced Prostate Cancer (CME/CE)

MedPageToday, 2012

(Jevtana) chemotherapy and the anti-androgen (Zytiga) as well as sipuleucel-T (Provenge) for asymptomatic or minimally symptomatic metastatic cases.
Placebo patients were allowed to go on subsequent therapies, with about 20% getting cabazitaxel or abiraterone, Scher pointed out.
"The benefit-to-risk profile will likely position it as the front-line agent after docetaxel therapy," Scher told reporters, adding, "I would say this should be approved relatively quickly."
Oliver Sartor, MD, of Tulane University in New Orleans, agreed that the drug was likely to be well received by the FDA based on its "excellent safety profile."
Serious adverse events, events leading to discontinuation, and those resulting in death were likewise less common with the novel anti-androgen.
Earlier phase results had raised some concern about , which had been noted with another androgen-receptor antagonist as well.
Five patients out of the 800 treated in AFFIRM with MDV3100 had seizures, for a rate of 0.6% compared with none in the placebo group.
The symposium is sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO), and the Society of Urologic Oncology.
Scher reported consulting or advising for Medivation and receiving research funding from the company.
"Effect of MDV3100, an androgen receptor signaling inhibitor (ARSI), on overall survival in patients with prostate cancer post-docetaxel: Results from the phase III AFFIRM study" MGUCS 2012; LBA 1.
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