) and partner
Astellas Pharma Inc.
) are looking to get the label for their prostate cancer
treatment, Xtandi, expanded into the chemo-naïve patient
population. The companies have filed a supplemental New Drug
Application (sNDA) seeking FDA approval for Xtandi for the
treatment of men with metastatic castration-resistant prostate
cancer (mCRPC) who have not received chemotherapy.
The sNDA is based on data from the phase III PREVAIL study.
Results from this study were pretty impressive with Xtandi
reducing the risk of death by 29% compared to placebo. Moreover,
the risk of radiographic progression or death was cut by 81% in
the Xtandi arm. A 17-month delay in the time to initiation of
chemotherapy was observed in the Xtandi arm.
Medivation also reported that most of the men with soft tissue
metastatic disease had objective responses in the Xtandi arm
compared to placebo (58.8% versus 5%) - complete response was
observed in 19.7% of patients in the Xtandi arm compared to just
1% in the placebo arm.
The median time to PSA progression was extended from 2.8
months in the case of placebo to 11.2 months in the case of
Xtandi. About 78% of patients in the Xtandi arm saw a PSA decline
of ≥50% compared to less than 4% in the placebo arm.
Xtandi is currently approved for the treatment of patients
with metastatic castration-resistant prostate cancer who have
previously received docetaxel. Medivation and Astellas intend to
apply for EU approval for the chemo-naïve indication later this
Expansion into the pre-chemo setting will be a major positive
for Medivation. The 17-month delay in the time to initiation of
chemotherapy should help Xtandi gain share once it is approved
for the pre-chemo patient population.
Medivation is a Zacks Rank #3 (Hold) stock. Some better-ranked
stocks in the biotech sector include companies like
Gilead Sciences Inc.
Alexion Pharmaceuticals, Inc.
). Both carry a Zacks Rank #1 (Strong Buy).
ASTELLAS PHARMA (ALPMY): Get Free Report
ALEXION PHARMA (ALXN): Free Stock Analysis
GILEAD SCIENCES (GILD): Free Stock Analysis
MEDIVATION INC (MDVN): Free Stock Analysis
To read this article on Zacks.com click here.