TOKYO, March 26, 2021 /PRNewswire/ -- Astellas Pharma
Inc. (TSE: 4503, President and CEO: Kenji
Yasukawa, Ph.D., "Astellas") announced today the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has adopted a positive opinion recommending
an additional indication for the oral once-daily therapy
XTANDITM (enzalutamide) for adult men with metastatic
hormone-sensitive prostate cancer (mHSPC, also known as metastatic
castration-sensitive prostate cancer or
mCSPC).1 Men diagnosed with mHSPC tend to have a
poor prognosis, with a median survival of approximately 3-4 years,
underscoring the need for new treatment options.2
If approved by the European Commission (EC), enzalutamide will
be the only oral treatment approved by the EC to treat three
distinct types of advanced prostate cancer — non-metastatic and
metastatic castration-resistant prostate cancer (CRPC) and
mHSPC.3 The CHMP decision is based on data from the
pivotal Phase 3 ARCHES trial investigating enzalutamide in men with
mHSPC.4
"This positive opinion from the CHMP is testament to our
continuing commitment to addressing unmet needs for men with
advanced prostate cancer," said Andrew
Krivoshik, M.D., Ph.D., Senior Vice President and Global
Therapeutic Area Head, Oncology Development, Astellas. "We are
excited to be another step closer to approval of enzalutamide for
the treatment of men with metastatic hormone-sensitive prostate
cancer in Europe."
Data from the ARCHES trial showed that enzalutamide plus
androgen deprivation therapy (ADT) significantly reduced the risk
of radiographic progression or death by 61% versus placebo plus ADT
in men with mHSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence
interval (CI): 0.30-0.50]; P<0.0001).4
The safety analysis of the ARCHES trial appears consistent with
the safety profile of enzalutamide in previous clinical trials in
CRPC. In ARCHES, Grade 3 or greater adverse events (AEs) (defined
as severe/disabling or life-threatening) were similar for patients
receiving both enzalutamide plus ADT and those who received placebo
plus ADT (24.3% vs. 25.6%).4
The positive opinion from the CHMP will now be reviewed by the
EC, which has the authority to approve medicines for European Union
member countries, as well as Iceland, Norway and Liechtenstein.5
Enzalutamide is currently approved in the EU for the treatment
of adult men with high-risk non-metastatic castration-resistant
prostate cancer (nmCRPC) and adult men with metastatic
castration-resistant prostate cancer (mCRPC) in whom chemotherapy
is not yet clinically indicated, or following disease progression
on or after docetaxel therapy.3 In the U.S.,
enzalutamide is approved in non-metastatic and metastatic CRPC as
well as metastatic castration-sensitive prostate cancer (mCSPC)
also referred to as mHSPC.6 In Japan, enzalutamide
is indicated for the treatment of prostate cancer with distant
metastasis, which includes mHSPC and CRPC.7,8
About metastatic Hormone-Sensitive Prostate Cancer
(mHSPC)
In men with prostate cancer, the disease is
considered metastatic once the cancer has spread outside of the
prostate gland to other parts of the body. Men are considered
hormone- (or castration-) sensitive if their disease still responds
to medical or surgical treatment to lower testosterone levels.
mHSPC has a median survival of approximately 3–4 years for men
starting treatment with ADT.2
About XTANDI™ (enzalutamide)
Enzalutamide is
currently indicated in the EU for:3
- the treatment of adult men with high-risk non-metastatic
castration-resistant prostate cancer (CRPC);
- the treatment of adult men with metastatic CRPC who are
asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy in whom chemotherapy is not yet clinically
indicated; and
- the treatment of adult men with metastatic CRPC whose disease
has progressed on or after docetaxel therapy.
Important Safety Information
For important Safety
Information for enzalutamide please see the full Summary of Product
Characteristics at:
https://www.medicines.org.uk/emc/product/3203.
About ARCHES
The company-sponsored, Phase 3,
randomized, double-blind, placebo-controlled, multinational ARCHES
trial (NCT02677896) enrolled 1,150 patients with mHSPC at sites in
the U.S., Canada, Europe, South
America, and the Asia-Pacific region. Patients in the trial
were randomized to receive enzalutamide 160 mg daily or placebo and
continued on a luteinizing hormone-releasing hormone (LHRH) agonist
or antagonist or had a history of bilateral orchiectomy. The
primary endpoint of the trial was radiographic progression-free
survival (rPFS) assessed by blinded independent central review.
rPFS was defined as the time from randomization to radiographic
disease progression at any time or death within 24 weeks after
study drug discontinuation. Radiographic disease progression was
defined by identification of two or more new bone lesions on a bone
scan with confirmation (Prostate Cancer Working Group 2 criteria)
and/or progression in soft tissue disease. Patients were stratified
by volume of disease (low vs high) and prior docetaxel therapy for
prostate cancer (no prior docetaxel, 1-5 cycles, or 6 prior
cycles).4
About Astellas
Astellas Pharma Inc., is a
pharmaceutical company conducting business in more than 70
countries around the world. We are promoting the Focus Area
Approach that is designed to identify opportunities for the
continuous creation of new drugs to address diseases with high
unmet medical needs by focusing on Biology and Modality.
Furthermore, we are also looking beyond our foundational Rx focus
to create Rx+® healthcare solutions that combine our
expertise and knowledge with cutting-edge technology in different
fields of external partners. Through these efforts, Astellas stands
on the forefront of healthcare change to turn innovative science
into value for patients. For more information, please visit our
website at https://www.astellas.com/en.
About the Pfizer/Astellas Collaboration
In
October 2009, Medivation, Inc, which
is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered
into a global agreement to jointly develop and commercialize
enzalutamide. The companies jointly commercialize enzalutamide in
the United States and Astellas has
responsibility for manufacturing and all additional regulatory
filings globally, as well as commercializing enzalutamide outside
the United States.
Astellas Cautionary Notes
In this press release,
statements made with respect to current plans, estimates,
strategies and beliefs and other statements that are not historical
facts are forward-looking statements about the future performance
of Astellas. These statements are based on management's current
assumptions and beliefs in light of the information currently
available to it and involve known and unknown risks and
uncertainties. A number of factors could cause actual results to
differ materially from those discussed in the forward-looking
statements. Such factors include, but are not limited to: (i)
changes in general economic conditions and in laws and regulations,
relating to pharmaceutical markets, (ii) currency exchange rate
fluctuations, (iii) delays in new product launches, (iv) the
inability of Astellas to market existing and new products
effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets, and (vi) infringements of
Astellas' intellectual property rights by third parties.
Information about pharmaceutical products (including products
currently in development) which is included in this press release
is not intended to constitute an advertisement or medical
advice.
References
1 European Medicines Agency. Meeting highlights from
the Committee for Medicinal Products for Human Use (CHMP)
September 2019. Available at:
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-march-2021.
Last accessed March 2021.
2 Mottet N, et al. Updated Guidelines for
Metastatic Hormone-sensitive Prostate Cancer: Abiraterone Acetate
Combined with Castration Is Another Standard. Eur Urol.
2018;3:316-321.
3 European Medicines Authority. Summary of
Product Characteristics: Xtandi 40 mg soft capsules. Available at:
https://www.medicines.org.uk/emc/product/3203/smpc. Last accessed
March 2021.
4 Armstrong A, et al. Phase 3 study of androgen
deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO)
in metastatic hormone-sensitive prostate cancer (mHSPC): the ARCHES
trial. J Clin Oncol. 2019;7:687.
5 European Medicines Agency. Authorization of
medicines. Available at:
https://www.ema.europa.eu/about-us/what-we-do/authorisation-medicines.
Last accessed March 2021.
6 Food and Drug Administration. Highlights of
prescribing information. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203415s015lbl.pdf.
Last accessed March 2021.
7 Pharmaceuticals and Medical Devices Agency.
Summary of Investigation Results Enzalutamide. Available at:
https://www.pmda.go.jp/files/000232289.pdf. Last accessed March
2021.
8 Astellas Press Release. XTANDI® (enzalutamide)
Approved by Japan MHLW for the Treatment of Prostate Cancer with
Distant Metastasis. Available at:
https://www.astellas.com/system/files/news/2020-05/20200529_en_1.pdf.
Last accessed March 2021.
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