) and partner,
Astellas Pharma Inc.
) recently enrolled the first patient in a phase II study being
conducted with their oncology product, Xtandi.
The open label, single-arm, multicenter study will evaluate
Xtandi as a monotherapy for the treatment of advanced, androgen
receptor (AR)-positive, triple-negative breast cancer (TNBC).
Meanwhile, results from a phase I breast cancer study on Xtandi
will be presented at an upcoming medical conference.
We note that Xtandi is already approved for the treatment of
patients with metastatic castration-resistant prostate cancer who
have previously received docetaxel. While Xtandi gained approval
in the US last year, EU approval was announced earlier this
Xtandi is off to a strong start with first quarter 2013 sales
coming in at $75.4 million, $18 million above the last quarter of
Medivation and Astellas are currently working on expanding
Xtandi's label. In addition to the breast cancer study,
Medivation is studying Xtandi in early stage prostate cancer
patients, which could represent a very big market for the
product. A phase III study (PREVAIL) in chemotherapy-naïve
advanced prostate cancer patients is currently ongoing with data
read-outs expected later this year.
Medivation is also evaluating Xtandi at the earliest stage of
prostate cancer, when the disease is initially diagnosed. The
company is conducting an open-label trial which will study Xtandi
as a new adjuvant therapy prior to prostatectomy. Moreover,
Medivation intends to start a phase III trial in patients with
non-metastatic castration-resistant prostate cancer this
Medivation currently carries a Zacks Rank #3 (Hold). At
present, companies like
) look well positioned with a Zacks Rank #1 (Strong Buy).
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