) and Astellas Pharma Inc. recently announced that the US Food and
Drug Administration (FDA) will deliver a decision regarding their
oncology candidate, enzalutamide, by November 22, 2012.
Medivation and Astellas are looking to get enzalutamide approved
for the treatment of men with castration-resistant prostate cancer
previously treated with docetaxel-based chemotherapy. The
companies are seeking EU approval as well for the candidate.
Enzalutamide is the lead pipeline candidate at Medivation.
Earlier this year, Medivation and Astellas had presented positive
results on enzalutamide from the phase III AFFIRM study that was
conducted in prostate cancer patients previously treated with
chemotherapy. The companies said that besides meeting the primary
and secondary endpoints, enzalutamide's safety profile was
Meanwhile, enzalutamide is in a phase III study (PREVAIL) which
is being conducted in chemotherapy naïve prostate cancer patients.
Enzalutamide is also in a phase II study (TERRAIN), which will
compare enzalutamide with bicalutamide, in advanced prostate cancer
patients who have progressed following medical castration with LHRH
analog therapy or surgical castration.
Another open-label phase II study is being conducted to evaluate
enzalutamide in advanced prostate cancer patients who have not had
any previous hormonal therapies. Enzalutamide is also being studied
for breast cancer (phase I).
With the FDA action date being announced, we expect investor
focus to remain on the regulatory status of the candidate.
Enzalutamide could very well be a game-changer for Medivation.
The prostate cancer market represents huge commercial potential.
According to the American Cancer Society, prostate cancer is the
most commonly diagnosed cancer among men in the US, other than skin
cancer. It is estimated by the American Cancer Society that about
241,740 new cases of prostate cancer will be diagnosed in the US in
2012 with 28,170 men expected to die from the disease.
Currently approved prostate cancer treatments include
) Jevtana and
Johnson and Johnson's
) Zytiga among others.
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