Astellas Highlights Progress to Advance Care of Patients with Genitourinary
Cancers at ASCO-GU Annual Meeting
NORTHBROOK, Ill., Feb. 13, 2013
NORTHBROOK, Ill., Feb. 13, 2013 /PRNewswire/ -- Astellas Pharma US, Inc., a
U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today
announced that more than 10 abstracts from Astellas oncology pipeline agents
and marketed products will be presented at the 2013 American Society of
Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU), to be held
February 14-16 in Orlando, Florida.
"We're committed to delivering new treatment options for patients with GU
cancers," said Mark Reisenauer, vice president, Astellas Oncology. "The data
to be presented at ASCO GU further illustrates the potential role our products
Key presentations to be made at ASCO-GU include:
Data from a 25-week, open label, single-arm phase 2 study highlighting the
effect of enzalutamide on prostate-specific antigen (PSA) response in men with
hormone-naive prostate cancer will be presented. Five additional abstracts
will highlight outcomes from a phase 1 study of enzalutamide in combination
with docetaxel chemotherapy, as well as additional findings from the
randomized, global, placebo-controlled phase 3 AFFIRM study of enzalutamide in
men with metastatic castration resistant prostate cancer. XTANDI was approved
by the FDA on August 31, 2012 for the treatment of patients with metastatic
castration-resistant prostate cancer who have previously received docetaxel
(chemotherapy). A Marketing Authorization Application for XTANDI is currently
under review by the European Medicines Agency (EMA).
Additional secondary analysis results from the Phase 3 TIVO-1 (tivozanib
versus sorafenib in 1st line advanced RCC) trial will be presented. Reported
data will include overall survival (OS) results for metastatic renal cell
carcinoma (mRCC) patients who received tivozanib versus patients who received
sorafenib in the TIVO-1 study. Additionally, four posters with tivozanib data
regarding the safety and efficacy profile of tivozanib will also be presented
at the meeting. A new drug application (NDA) for tivozanib, an investigational
agent, is currently under review by the FDA for the treatment of patients
with advanced renal cell carcinoma.
"We applaud companies such as Astellas that are committed to developing
medicines for difficult-to-treat cancers," said Helen Miller, LCSW, CancerCare
CEO. "We share their commitment to put cancer patients first."
Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S. affiliate
of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceutical products. The organization
is committed to becoming a global category leader in oncology, and has several
oncology products on the market and compounds in development. Astellas is
proud to be an award recipient of the CEO Gold Standard Accreditation from the
CEO Roundtable on Cancer. For more information on Astellas Pharma Inc., please
visit our website at www.astellas.us.
XTANDI® (enzalutamide) capsules is an oral, once-daily androgen receptor
inhibitor. XTANDI was approved by the FDA on August 31, 2012 for the treatment
of metastatic castration-resistant prostate cancer for patients who have
previously received docetaxel (chemotherapy). A Marketing Authorization
Application for XTANDI is currently under review by the European Medicines
The efficacy and safety of XTANDI were assessed in the randomized,
placebo-controlled, global phase 3 AFFIRM clinical trial. A total of 1,199
patients with mCRPC who had previously received docetaxel were randomized 2:1
to receive either XTANDI orally at a dose of 160 mg once daily (N = 800) or
placebo (N = 399). 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. The primary endpoint of the
trial was OS.
XTANDI-treated patients had a statistically-significant improvement in median
OS compared to the placebo group: 18.4 months in the XTANDI group versus 13.6
months in the placebo group (P < 0.0001). XTANDI provided a 37% reduction in
risk of death compared to placebo (hazard ratio = 0.631). Seizure occurred in
0.9% of patients on XTANDI and 0% of the placebo-treated patients. The most
common adverse reactions (≥ 5%) are 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 3 and higher adverse
reactions were reported among 47% of XTANDI-treated patients and 53% of
The recommended dose of XTANDI is 160 mg (four 40 mg capsules) administered
orally once daily. XTANDI can be taken with or without food and does not
require concomitant steroid (e.g., prednisone) use. In the phase 3 clinical
trial, 48% of XTANDI patients and 46% of patients in the placebo arm were
treated with glucocorticoids.
XTANDI Mechanism of Action
XTANDI (enzalutamide) is an androgen receptor inhibitor that acts on different
steps in the androgen receptor signaling pathway. XTANDI has been shown to
competitively inhibit androgen binding to androgen receptors, inhibit androgen
receptor nuclear translocation and interaction with DNA. A major metabolite,
N-desmethyl enzalutamide, exhibited similar in vitro activity to XTANDI.
XTANDI decreased proliferation and induced cell death of prostate cancer cells
in vitro, and decreased tumor volume in a mouse prostate cancer xenograft
Important Safety 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 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
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, please visit www.XtandiHCP.com.
Tivozanib is a potent, selective and long half-life inhibitor of all three
vascular endothelial growth factor (VEGF) receptors that is designed to
optimize VEGF blockade while minimizing off-target toxicities. Tivozanib is an
oral, once-daily, investigational tyrosine kinase inhibitor for which positive
results from a Phase 3 clinical study in advanced RCC have been reported, and
is being evaluated in other tumors.
SOURCE Astellas Pharma US, Inc.
Contact: Jenny Kite, Astellas, +1-224-205-5405, firstname.lastname@example.org
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