NORTHBROOK, Ill. and
SAN FRANCISCO, May 14, 2014 /PRNewswire/ -- Astellas Pharma
US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503) and Medivation, Inc. (Nasdaq:
MDVN) announced that eight enzalutamide abstracts will be presented
at the 2014 American Society of Clinical Oncology (ASCO) Annual
Meeting, May 30-June 3 in
Chicago.
The following abstract will be presented during an oral
presentation:
Title: (Abstract 5007) Primary, secondary, and
quality-of-life endpoint results from PREVAIL, a phase 3 study of
enzalutamide in men with metastatic castration resistant prostate
cancer (mCRPC).
Presenter: Andrew J.
Armstrong, MD, ScM, FACP
- Session Date/Time: Sunday, June
1, 10:24 AM – 10:36 AM
- Session Detail: North Hall B1
Seven additional enzalutamide abstracts will be presented during
General Poster Sessions:
- (Abstract 5054) Sensitivity analyses for radiographic
progression-free survival (rPFS): results from the phase 3 PREVAIL
trial comparing enzalutamide to placebo (Poster Board #183,
1:15-5:00 PM, Monday, June 2, South Hall A2)
- (Abstract 5051) Safety results of the enzalutamide expanded
access program in the United
States and Canada for
patients with metastatic castration-resistant prostate cancer
(mCRPC) previously treated with docetaxel (Poster Board #180,
1:15-5:00 PM, Monday, June 2, South Hall A2)
- (Abstract TPS5094) PROSPER: A phase 3 study of enzalutamide in
nonmetastatic (M0) castration-resistant prostate cancer (CRPC)
patients. (Poster Board #223A, 1:15-5:00
PM, Monday, June 2, South Hall
A2)
- (Abstract 5068) Enzalutamide monotherapy: 1-year extended
follow-up of a Phase 2 study in hormone-naïve prostate cancer
patients (Poster Board #197, 1:15-5:00
PM, Monday, June 2, South Hall
A2)
- (Abstract 545) Enzalutamide plus exemestane: a pilot study to
assess safety, pharmacokinetics, and effects on circulating
estrogens in women with advanced hormone-positive breast
cancer (Poster Board #9, 8:00-11:45
AM, Monday, June 2, South Hall
A2)
- (Abstract TPS1144) A phase 2 single-arm study of the clinical
activity and safety of enzalutamide in patients with advanced
androgen receptor-positive, triple-negative breast cancer (Poster
Board #232A, 8:00-11:45 AM,
Monday, June 2, South Hall A2)
- (Abstract TPS653) A phase 2 randomized, double-blind,
placebo-controlled multicenter trial evaluating the efficacy and
safety of enzalutamide in combination with exemestane in estrogen
or progesterone receptor-positive and HER2 normal advanced breast
cancer (Poster Board #116B, 8:00-11:45
AM, Monday, June 2, South Hall
A2)
Enzalutamide Mechanism of Action
Enzalutamide
is an androgen receptor inhibitor that acts on different steps in
the androgen receptor signaling pathway. Enzalutamide has been
shown to competitively inhibit androgen binding to androgen
receptors, and inhibit androgen receptor nuclear translocation and
interaction with DNA.
About XTANDI® (enzalutamide) capsules
XTANDI
was approved by the FDA on August 31,
2012 and is indicated for the treatment of patients with
metastatic castration-resistant prostate cancer (mCRPC) who have
previously received docetaxel.
Important Safety Information for XTANDI (from the approved
prescribing information) Contraindications -
XTANDI can cause fetal harm when administered to a pregnant woman
based on its mechanism of action. XTANDI is not indicated for use
in women. XTANDI is contraindicated in women who are or may become
pregnant.
Warnings and Precautions - In the randomized
clinical trial, seizure occurred in 0.9% of patients on XTANDI. No
patients on the placebo arm experienced seizure. Patients
experiencing a seizure were permanently discontinued from therapy.
All seizures resolved. Patients with a history of seizure, taking
medications known to decrease the seizure threshold, or with other
risk factors for seizure were excluded from the clinical trial.
Because of the risk of seizure associated with XTANDI use, patients
should be advised of the risk of engaging in any activity where
sudden loss of consciousness could cause serious harm to themselves
or others.
Adverse Reactions - The most common adverse drug
reactions (≥ 5%) reported in patients receiving XTANDI in the
randomized clinical trial were asthenia/fatigue, back pain,
diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal
pain, headache, upper respiratory infection, muscular weakness,
dizziness, insomnia, lower respiratory infection, spinal cord
compression and cauda equina syndrome, hematuria, paresthesia,
anxiety, and hypertension. Grade 1-4 neutropenia occurred in 15% of
XTANDI patients (1% Grade 3-4) and in 6% on placebo (no Grade 3-4).
Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients
and 2% on placebo. One percent of XTANDI patients compared to 0.3%
on placebo died from infections or sepsis. Falls or injuries
related to falls occurred in 4.6% of XTANDI patients versus 1.3% on
placebo. Falls were not associated with loss of consciousness or
seizure. Fall-related injuries were more severe in XTANDI patients
and included non-pathologic fractures, joint injuries, and
hematomas. Grade 1 or 2 hallucinations occurred in 1.6% of XTANDI
patients and 0.3% on placebo, with the majority on
opioid-containing medications at the time of the event.
Drug Interactions - Effect of Other Drugs on
XTANDI: Administration of strong CYP2C8 inhibitors can increase
the plasma exposure to XTANDI. Co-administration of XTANDI with
strong CYP2C8 inhibitors should be avoided if possible. If
co-administration of XTANDI cannot be avoided, reduce the dose of
XTANDI. Co-administration of XTANDI with strong or moderate CYP3A4
and CYP2C8 inducers can alter the plasma exposure of XTANDI and
should be avoided if possible.
Effect of XTANDI on Other Drugs - XTANDI is a
strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in
humans. Avoid CYP3A4, CYP2C9 and CYP2C19 substrates with a narrow
therapeutic index, as XTANDI may decrease the plasma exposures of
these drugs. If XTANDI is co-administered with warfarin (CYP2C9
substrate), conduct additional INR monitoring. For Full Prescribing
Information for XTANDI (enzalutamide) capsules, please visit
www.XtandiHCP.com.
About Astellas Pharma Inc.
Astellas Pharma
Inc. is a pharmaceutical company dedicated to improving the health
of people around the world through provision of innovative and
reliable pharmaceuticals. The organization is committed to being a
global category leader in Oncology and Urology, and has several
oncology compounds in development in addition to enzalutamide. For
more information on Astellas Pharma Inc., please visit our website
at www.astellas.com/en.
About Medivation
Medivation, Inc. is a
biopharmaceutical company focused on the rapid development of novel
small molecule drugs to treat serious diseases for which there are
limited treatment options. Medivation aims to transform the
treatment of these diseases and offer hope to critically ill
patients and their families. For more information, please visit us
at www.medivation.com.
About the Astellas/Medivation Collaboration
In
October 2009, Medivation and Astellas
entered into a global agreement to jointly develop and
commercialize enzalutamide. The companies are collaborating on a
comprehensive development program that includes studies to develop
enzalutamide across the full spectrum of advanced prostate cancer
as well as advanced breast cancer. The companies jointly
commercialize XTANDI in the United
States and Astellas has responsibility for manufacturing and
all additional regulatory filings globally, as well as
commercializing XTANDI outside the United
States.
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SOURCE Astellas Pharma US, Inc.
