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Q & A
Dr. cy stein sees a role for zytiga, Jevtana and enzalutamide in Prostate cancer

Q: have you faced any issues with re-
enzalutamide in the first-line setting?
cy stein, M.D., Ph.D., an oncologist special-
imbursement? how has J&J marketed
a: It could be better than Casodex but
izing in the biology and treatment of genitouri- nary cancers, discussed recent developments a: Some patients are not covered for Zytiga.
in prostate cancer with Elizabeth Krutoholow. J&J has done a brilliant job marketing the Q: if enzalutamide proves effective as
The subtle differences between Johnson & drug. It’s very easy to communicate its ben- a front-line therapy and has an over-
Johnson’s Zytiga and Medivation’s enzalu-tamide could create a marketing battle.
efits scientifically and they have gone all out.
all survival benefit in its label, would
this encourage use over Zytiga if it
Q: if Medivation’s enzalutamide is
only is labeled for a progression-free
Q: What is your standard approach for
approved, how will it fit into the treat-
survival benefit?
treating metastatic castrate resistant
ment paradigm with Zytiga, Provenge
a: The overall survival data for enzalu-
prostate cancer?
and Jevtana?
a: There is no standard approach and
a: Enzalutamide is another good drug.
Phase III trial in the front-line setting did I am waiting for the published data on it. have two primary endpoints and it only hit How will it fit with Zytiga? If a patient has one-progression free survival. Zytiga did drug-dendreon’s Provenge.
not reach overall survival but this data is Q: how would you describe your expe-
However, it won’t be a question of either received afterwards anyway. Also, in the rience with Provenge?
or with these drugs and patients will be a: I have used Provenge in the hospital
given what they can tolerate. The fact that sion free survival since I am just trying to setting, so I have not had any issues with Zytiga must be given with steroids while put off giving taxotere so overall survival reimbursement and I select patients that enzalutamide does not is not a major sell- will not be turned down. There is a fear ing point for Medivation. Prednisone is not FDA will approve it for first-line use with- a rough drug. Jevtana is also a very good out overall survival remains unclear.
drug and I have seen fantastic results with it. It tends to be more toxic and Sanofi did Q: What other experimental therapies
not market it as well as J&J has marketed are you most interested in?
months in two Phase III trials but it does Zytiga. Also, many think that Jevtana is a: aragon Pharmaceuticals’ ARN-509 is
just another taxane but it really is different.
vival and we cannot assess how a patient me-too drug. takeda’s TAK-700 looks
is doing. If there is new objective disease, I Q: since Zytiga and enzalutamide have
then treat with ketoconazole which is a ge- different mechanisms of action, could
Zytiga. There is also galeterone from tokai
neric drug that is similar to Zytiga and very the two be combined?
Pharmaceuticals, which is a small com-
inexpensive. It is more toxic than Zytiga, a: The combination may be cost-pro-
pany in Cambridge. This is very similar to but provides about a 50 percent response hibitive but it would be great to combine Zytiga but they have had positive Phase I/ II results. None of the drugs we have so far dose to alleviate some of the toxicity. Also, are a homerun as they only help about 50 Zytiga is not yet approved for use before percent of patients and all provide incre- taxotere. Once patients fail on taxotere, mental benefits. These are elderly patients then we look toward new medications.
though so any benefit is a good thing. Still, some patients do really well and having Q: What is your experience with John-
Q: What are your expectations for
son & Johnson’s Zytiga?
a:
Zytiga is a good drug. It is pretty non-
toxic with some mineralocorticoid side
effects. The response rates with Zytiga
Role: Chair of the Department of Medical Oncology & Therapeutics
depend on whether or not a patient has had prior treatment with ketoconazole. Re- Research, City of Hope comprehensive cancer center, Duarte, CA sponse rates are lowered in patients who Awards: Named top physician in his field by New York Times Magazine
have taken it because the drugs have a similar mechanism. I won’t deny a patient ketoconazole for this reason though since Summer Plans: Spending time in New York with his first granddaughter
I am trying to stretch a patient for as long who was born 8 weeks premature and is doing very well

Source: http://www.bloombergbriefs.com/files/HEA-8.6.12_pg12.pdf

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