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Medivation, Inc.

Partner : Astellas Pharma

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February 22, 2016

FDA Accepts for Review Supplemental New Drug Application for XTANDI(R) (enzalutamide) Capsules in Metastatic Castration-Resistant Prostate Cancer With Data From Head-to-Head Studies of Enzalutamide Versus Bicalutamide

SAN FRANCISCO, CA and TOKYO, JAPAN -- (Marketwired) -- 02/22/16 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI® (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.

A Type-II variation to update the Summary of Product Characteristics (SmPC) has also been submitted to the European Medicines Agency.
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Source: press release, 2/22/16. http://investors.medivation.com/releasedetail.cfm?ReleaseID=956224

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Xtandi (Enzalutamide) (MDV3100) Prostate CancerUrologyProstate cancerAndrogen receptor (AR) antagonistAndrogen Receptor (AR)

Mechanism of action: Xtandi (Enzalutamide) (MDV3100) is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor (AR) with potential antineoplastic activity. Through a mechanism that is reported to be different from other approved AR antagonists, enzalutamide inhibits the activity of prostate cancer cell ARs, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum prostate specific antigen (PSA) level. AR over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-10-22

Results: Pending