XTANDI(R) (Enzalutamide) Capsules Receives Health Canada Approval for Treatment
of Metastatic Castration-Resistant Prostate Cancer in
Patients Previously Treated With Docetaxel
TOKYO and SAN FRANCISCO, CA -- (Marketwired) -- 06/03/13 -- Astellas
Pharma Inc. (TSE: 4503) and Medivation, Inc. (NASDAQ: MDVN) today
announced that after a priority review, Health Canada has approved
XTANDI(R) (enzalutamide) capsules for the treatment of patients with
metastatic castration-resistant prostate cancer in the setting of
medical or surgical castration who have received docetaxel therapy.
XTANDI(R) (enzalutamide) capsules is an oral, once-daily androgen
receptor inhibitor. XTANDI was approved by the U.S. Food and Drug
Administration on August 31, 2012 for the treatment of patients with
metastatic castration-resistant prostate cancer who have previously
received docetaxel (chemotherapy). On April 26, 2013, the Companies
received a positive opinion from the European Medicines Agency's
Committee for Medicinal Products for Human Use, recommending European
Commission approval for XTANDI. An application for marketing approval
was submitted to the Ministry of Health, Labour and Welfare in Japan
for the treatment of prostate cancer on May 24, 2013.
Important US Label Safety Information for XTANDI
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 vs 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
For Full Prescribing Information, please visit www.XtandiHCP.com.
Medivation, Inc. is a biopharmaceutical company
focused on the rapid development of novel therapies 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 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 becoming a global category leader in
Oncology, 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.
Chief Business & Financial Officer
Senior Director, Investor Relations
Sam Brown, Inc (media for both companies)
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