Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company
developing innovative medicines and imaging analysis technology for
targeting and treating cancer, today announced that AZEDRA®
(iobenguane I 131), the Company’s radiotherapeutic, has been added
to the National Comprehensive Cancer Network® (NCCN) Clinical
Practice Guidelines in Oncology for Neuroendocrine and Adrenal
Tumors v 3.2018. NCCN Guidelines® are widely recognized and
used as the standard for clinical policy in oncology by clinicians
and payors.
NCCN Guidelines have been updated with AZEDRA,
the first and only FDA approved treatment of patients 12 and older
with iobenguane scan positive, locally unresectable and metastatic
pheochromocytoma or paraganglioma. Pheochromocytoma and
paraganglioma are rare neuroendocrine cancers that arise from cells
in and around the adrenal glands. Pheochromocytoma and
paraganglioma tumors frequently secrete high levels of hormones
that can lead to life-threatening high blood pressure, heart
failure, and stroke in these patients. Metastatic
pheochromocytoma and paraganglioma may result in unresectable
disease with a poor prognosis, including a five-year survival rate
as low as 12%1. Before AZEDRA’s approval in July of 2018, there
were no FDA-approved anti-tumor therapeutics for these
cancers.
“NCCN is considered the arbiter of high-quality
cancer care and we are extremely pleased that they have added
AZEDRA to their Guidelines for the treatment of pheochromocytoma
and paraganglioma,” said Mark Baker, Chief Executive Officer of
Progenics. “Inclusion in the NCCN Guidelines provides further
validation of AZEDRA’s value and will help raise awareness of this
breakthrough in treatment for these rare, life-threatening
tumors.”
The NCCN, a not-for-profit alliance of 27
leading cancer centers devoted to patient care, research, and
education, is dedicated to improving the quality, effectiveness,
and efficiency of cancer care so that patients can live better
lives. Through the leadership and expertise of clinical
professionals at NCCN Member Institutions, NCCN develops
resources that present valuable information to the numerous
stakeholders in the health care delivery system. NCCN promotes
the importance of continuous quality improvement and recognizes the
significance of creating clinical practice guidelines appropriate
for use by patients, clinicians, and other health care
decision-makers.
Approved Use:
AZEDRA® (iobenguane I 131) is a
prescription medicine used to treat adult and pediatric patients 12
years and older with cancers known as pheochromocytoma and
paraganglioma that are positive for the norepinephrine transporter
(as determined by an iobenguane scan), and who require systemic
anticancer therapy.
Important Safety
Information
AZEDRA can cause serious side effects. If
you experience these side effects, your health care provider may
need to adjust or stop your treatment. You should always
follow your health care provider’s instructions. Serious side
effects may include: Radiation
exposure: Treatment with AZEDRA will expose you to
radiation which can contribute to your overall long-term radiation
exposure. Overall radiation exposure is associated with an
increased risk for cancer. Radiation risk is greater in
children than in adults. You should stay well hydrated
before, during, and after your treatment and urinate
frequently. Your doctor will advise you on how to lessen
exposure to people who may come into contact with you after AZEDRA
treatment. Bone marrow problems and other
cancers: Treatment with AZEDRA may cause your blood
cell counts to drop (myelosuppression). You may experience
blood-related side effects such as low numbers of cells that are
responsible for blood clotting (thrombocytopenia), low numbers of a
type of white blood cells (neutropenia), and low red blood cells
(anemia). Among the 88 patients who received a therapeutic
dose of AZEDRA, 33% experienced Grade 4 thrombocytopenia, 16%
experienced Grade 4 neutropenia, and 7% experienced Grade 4 anemia.
Five percent of patients experienced febrile neutropenia
(neutropenia with fever). People with low blood counts can
develop serious infections. Your health care provider will
routinely check your blood counts and tell you if they are too
low. Tell your doctor if you experience any symptoms of low
blood counts or infection, such as fever, chills, dizziness,
shortness of breath, or increased bleeding or bruising. Your
health care provider may need to adjust or stop your treatment
accordingly. Other conditions that you may develop as a
direct result of treatment with AZEDRA are blood and bone marrow
cancers known as secondary myelodysplastic syndrome (MDS) and
leukemia. MDS or acute leukemias were reported in 6.8% of the 88
patients who received a therapeutic dose of AZEDRA. The time
to development of MDS or acute leukemia ranged from 12 months to 7
years. Two of the 88 patients developed other types of
cancer. Thyroid problems: Treatment
with AZEDRA may increase your long-term risk of developing an
underactive thyroid (hypothyroidism) or thyroid cancer.
Hypothyroidism was reported in 3.4% of the 88 patients who received
a therapeutic dose of AZEDRA. Take all thyroid-blocking
agents as prescribed by your doctor to reduce the risk of these
problems. You may need life-long monitoring for signs and
symptoms of hypothyroidism. Elevations in blood
pressure: During or 24 hours following AZEDRA
treatment, you may experience increases of blood pressure
(hypertension) as a result of hormones released from your
cancer. Eleven percent of the 88 patients who received a
therapeutic dose of AZEDRA experienced a worsening of pre-existing
hypertension. All changes in blood pressure occurred within the
first 24 hours after treatment. No life-threatening
hypertensive crises have been observed. Monitor blood pressure
frequently during the first 24 hours after each therapeutic dose of
AZEDRA. Tell your doctor if you experience any
cardiac-related symptoms.
Kidney problems: Treatment
with AZEDRA will expose your kidneys to radiation and may impair
their ability to work as normal. In some cases, patients have
experienced kidney failure after treatment with AZEDRA. Of
the 88 patients who received a therapeutic dose of AZEDRA, 9%
developed kidney failure or acute kidney injury, and 22%
experienced a decrease in kidney function measured at 6 or 12
months. Your health care provider will monitor your kidneys
after treatment using blood tests, particularly if you already have
kidney impairment before treatment. Respiratory
problems: Treatment with AZEDRA may cause
noninfectious lung inflammation (pneumonitis). Tell your
doctor if you experience shortness of breath, difficulty breathing,
or cough. Pregnancy warning: Before treatment
with AZEDRA, tell your doctor if you are pregnant or plan to become
pregnant. Exposure to radiation from treatment with AZEDRA
can harm your unborn baby. Use an effective method of birth
control during treatment with AZEDRA and for 7 months (for females)
and 4 months (for males) after your final dose. Do not
breastfeed during treatment with AZEDRA and for 80 days after your
final dose. Fertility problems: Treatment
with AZEDRA may cause infertility due to radiation absorbed by your
testes or ovaries over the treatment period that is within the
range of exposure where temporary or permanent infertility may be
expected.
The most common and most serious side effects of
AZEDRA include decreased blood cell counts, nausea, vomiting and
fatigue. These are not all the possible side effects of
AZEDRA. For more information, ask your health care
provider.
Drugs that reduce catecholamine uptake or that
deplete catecholamine stores may interact with AZEDRA and may
affect how well it works. These drugs were not permitted in the
clinical trials. Tell your doctor before starting any medication,
including over the counter medications, herbal or dietary
supplements.
You are encouraged to report negative side
effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information
for AZEDRA.
Distributed by: Progenics Pharmaceuticals, Inc.,
NY 10007
Reference:
AZEDRA® prescribing information. New York, NY: Progenics
Pharmaceuticals, Inc.; 08 2018.
About Progenics
Progenics develops innovative medicines and
other technologies to target and treat cancer, including:
therapeutic agents designed to treat cancer (AZEDRA®, 1095, and
PSMA TTC); prostate-specific membrane antigen (“PSMA”) targeted
imaging agents for prostate cancer (1404 and PyLTM); and imaging
analysis technology. Progenics has two commercial products,
RELISTOR® (methylnaltrexone bromide) subcutaneous injection for the
treatment of opioid-induced constipation, which is partnered with
Salix Pharmaceuticals, Inc. (a wholly-owned subsidiary of Bausch
Health Companies Inc. (formerly known as Valeant Pharmaceuticals
International, Inc.)); and AZEDRA, for the treatment of patients
with unresectable, locally advanced or metastatic pheochromocytoma
or paraganglioma (rare neuroendocrine tumors of neural crest
origin) who require systemic anticancer therapy.
This press release contains "forward-looking
statements" regarding future events. Statements contained in this
communication that refer to Progenics' estimated or anticipated
future results or other non-historical facts are forward-looking
statements that reflect Progenics' current perspective of existing
trends and information as of the date of this communication.
Forward looking statements are generally accompanied by words such
as "anticipate," "believe," "plan," "could," "should," "estimate,"
"expect," "forecast," "outlook," "guidance," "intend," "may,"
"might," "will," "possible," "potential," "predict," "project," or
other similar words, phrases or expressions. Such statements are
predictions only, and are subject to risks and uncertainties that
could cause actual events or results to differ materially. These
risks and uncertainties include, among others, the cost, timing and
unpredictability of results of clinical trials and other
development activities and collaborations, such as the Phase 3
clinical program for 1404; market acceptance for approved products;
the effectiveness of the efforts of our partners to market and sell
products on which we collaborate and the royalty revenue generated
thereby; generic and other competition; the possible impairment of,
inability to obtain and costs of obtaining intellectual property
rights; possible product safety or efficacy concerns, general
business, financial, regulatory and accounting matters, litigation
and other risks. More information concerning Progenics and such
risks and uncertainties is available on its website, and in its
press releases and reports it files with the U.S. Securities and
Exchange Commission, including those risk factors included in its
Annual Report on Form 10-K for the fiscal year ended December 31,
2017, as updated in its subsequent Quarterly Reports on Form 10-Q.
Progenics is providing the information in this press release as of
its date and, except as expressly required by law, Progenics
disclaims any intent or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or circumstances or otherwise.
Additional information concerning Progenics and
its business may be available in press releases or other public
announcements and public filings made after this release. For more
information, please visit www.progenics.com. Information on or
accessed through our website or social media sites is not included
in the company's SEC filings.
(PGNX-F)
Contact: Melissa Downs Investor Relations (646)
975-2533 mdowns@progenics.com 1Park, J., Korean J Urology
2011;52:241-246.
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