- GE Healthcare to scale Zionexa’s FDA-approved PET imaging
agent, Cerianna (fluoroestradiol F-18), used as an adjunct to
biopsy for the detection of estrogen receptor (ER) positive lesions
to help inform treatment selection for patients with recurrent or
metastatic breast cancer
- Aims to make Cerianna available to 75% of metastatic breast
cancer patients in the U.S. by 2023
- Acquisition demonstrates GE Healthcare’s commitment to its
precision health vision and builds additional pipeline of oncology
and neurology tracers to help physicians personalize treatment
GE Healthcare today announced the acquisition of Zionexa, a
leading innovator of in-vivo oncology and neurology biomarkers that
help enable more personalized healthcare. The company aims to
develop and bring to market Zionexa’s pipeline biomarkers, as well
as the recently FDA-approved PET imaging agent, Cerianna™
(fluoroestradiol F-18), which is used as an adjunct to biopsy for
the detection of estrogen receptor (ER) positive lesions to help
inform treatment selection for patients with recurrent or
metastatic breast cancer.
It is estimated that 168,000 people have metastatic breast
cancer (“Stage 4”) in the U.S.1, with a five-year survival rate of
28 percent2. Cerianna has been commercially available in the U.S.
since December 2020 and today is accessible to approximately 25
percent of the relevant patient population. By leveraging its
Molecular Imaging Supply Chain, R&D, Medical Affairs, Market
Access, Regulatory, Quality and Commercial expertise, GE
Healthcare’s Pharmaceutical Diagnostics business - the global
leader in pharmaceutical imaging agents - aims to scale Cerianna to
be accessible to a minimum of 75 percent of patients by 2023.
Kevin O’Neill, President and CEO of GE Healthcare Pharmaceutical
Diagnostics, said: “Like GE Healthcare, Zionexa’s products are
aimed at enabling more precise diagnosis, improved treatment
decision-making and ultimately better clinical outcomes for
patients. This acquisition further demonstrates our commitment to
enabling precision health and providing innovations that support
oncologists, nuclear medicine specialists and other physicians
throughout a cancer patient’s journey, from initial screening and
diagnosis to informing therapy selection and monitoring the
effectiveness of treatment.”
Zionexa, a privately owned company, formed in 2018 and
headquartered in Aubière, France, employs 24 people in France and
the U.S., all of whom will transfer to GE Healthcare. Additionally,
GE Healthcare will hire approximately 70 new dedicated employees
within the company’s U.S. Pharmaceutical Diagnostics team,
headquartered in Marlborough, Massachusetts.
Olivier Carli, President of Denos, the majority owner of
Zionexa, said: "We expect GE Healthcare Pharmaceutical Diagnostics'
acquisition to allow Zionexa to accelerate the development of its
promising R&D pipeline as well as its commercial footprint,
while providing Zionexa's team with access to global and
complementary expertise."
Currently, when treating metastatic breast cancer patients,
oncologists base clinical decisions on biopsy results which only
represent the sampled area of the tumor. However, estrogen receptor
(ER) expression – one of the most common breast cancer biomarkers -
can vary both within the primary tumor and across different
lesions3. Cerianna, an adjunct to biopsy, widens the diagnostic
lens for oncologists with a whole-body view of ER positive lesions,
helping to provide the patient with a more informed diagnosis,
potentially enabling more targeted and individualized treatment
plans and avoiding the selection of inappropriate or less effective
therapies.
Dr. Hannah M Linden, Breast Medical Oncologist, UW Medicine,
University of Washington Fred Hutchison Cancer Research Center and
Seattle Cancer Care Alliance in Seattle, who has conducted research
and authored multiple papers on fluoroestradiol F-18, explained:
“Making Cerianna more widely available is an important moment for
cancer patients and a significant step forward for molecular
imaging. We test ER expression in a metastatic biopsy once at the
beginning of the patient's journey and we make decisions all along
- when to give chemotherapy, when to use endocrine therapy, whether
or not to use targeted agents - based on that one measurement.
Since we know that ER expression can change with time and
treatment, imaging with 18F-fluoroestradiol at critical decision
points could help clinicians predict response to endocrine therapy
and select optimal treatment timing and sequencing.”
GE Healthcare Pharmaceutical Diagnostics imaging agents support
three patient procedures every second worldwide across MRI,
X-ray/CT, ultrasound and nuclear medicine imaging.
The financial terms of the acquisition are not being
disclosed.
About GE Healthcare:
GE Healthcare is the $18 billion healthcare business of GE
(NYSE: GE). As a leading global medical technology, pharmaceutical
diagnostics and digital solutions innovator, GE Healthcare enables
clinicians to make faster, more informed decisions through
intelligent devices, data analytics, applications and services,
supported by its Edison intelligence platform. With over 100 years
of healthcare industry experience and around 47,000 employees
globally, the company operates at the center of an ecosystem
working toward precision health, digitizing healthcare, helping
drive productivity and improve outcomes for patients, providers,
health systems and researchers around the world. Follow us on
Facebook, LinkedIn, Twitter, and Insights for the latest news, or
visit our website www.gehealthcare.com for more information. For
information about GE’s forward-looking statements, see
https://www.ge.com/investor-relations/important-forward-looking-statement-information
About Zionexa:
Zionexa is an international and innovative company developing
and commercializing in-vivo biomarkers for guiding targeted
therapies in oncology, to improve patients’ pathway and provide
them a better quality of life.
For more information, please visit www.zionexa.com
About Cerianna:
Cerianna (fluoroestradiol F-18) is a new molecular imaging agent
approved by the Food and Drug Administration (FDA) indicated for
use in positron emission tomography (PET) imaging for the detection
of estrogen receptor-positive lesions as an adjunct to biopsy in
patients with recurrent or metastatic breast cancer. Cerianna
(fluoroestradiol F-18) is the first FDA-approved F-18 PET imaging
agent specifically indicated for use in patients with recurrent or
metastatic breast cancer.
For more information about Cerianna, please visit
www.cerianna.com (accessible only for US HCPs) and find full
Prescribing Information here.
Important Safety Information for Cerianna™ (fluroestradiol F
18) Injection
INDICATIONS AND USAGE
CERIANNA is indicated for use with positron emission tomography
(PET) imaging for the detection of estrogen receptor (ER)-positive
lesions as an adjunct to biopsy in patients with recurrent or
metastatic breast cancer.
Limitations of Use
Tissue biopsy should be used to confirm recurrence of breast
cancer and to verify ER status by pathology. CERIANNA is not useful
for imaging other receptors, such as human epidermal growth factor
receptor 2 (HER2) and the progesterone receptor (PR).
Important Safety
Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Risk of Misdiagnosis
Inadequate Tumor
Characterization and Other ER-Positive Pathology
Breast cancer may be heterogeneous within
patients and across time. CERIANNA images ER and is not useful for
imaging other receptors such as HER2 and PR. The uptake of
fluoroestradiol F 18 is not specific for breast cancer and may
occur in a variety of ER-positive tumors that arise outside of the
breast, including from the uterus and ovaries. Do not use CERIANNA
in lieu of biopsy when biopsy is indicated in patients with
recurrent or metastatic breast cancer.
False Negative CERIANNA
Scan
A negative CERIANNA scan does not rule out
ER-positive breast cancer. Pathology or clinical characteristics
that suggest a patient may benefit from systemic hormone therapy
should take precedence over a discordant negative CERIANNA
scan.
Radiation Risks
Diagnostic radiopharmaceuticals, including
CERIANNA, expose patients to radiation. Radiation exposure is
associated with a dose-dependent increased risk of cancer. Ensure
safe drug handling and patient preparation procedures (including
adequate hydration and voiding) to protect patients and health care
providers from unintentional radiation exposure.
Pregnancy Status
Assessment of pregnancy status is recommended
in females of reproductive potential before administering
CERIANNA.
ADVERSE REACTIONS
In Clinical Trials (n=1207) the most common adverse reactions
seen occurred at a rate < 1%: were injection-site pain and
dysgeusia.
USE IN SPECIFIC
POPULATIONS
Pregnancy
Risk Summary
All radiopharmaceuticals, including CERIANNA,
have the potential to cause fetal harm depending on the fetal stage
of development and the magnitude of radiation dose. Advise a
pregnant woman of the potential risks of fetal exposure to
radiation from administration of CERIANNA.
There are no available data on CERIANNA use
in pregnant women. No animal reproduction studies using
fluoroestradiol F 18 have been conducted to evaluate its effect on
female reproduction and embryo-fetal development.
The estimated background risk of major birth
defects and miscarriage for the indicated populations is unknown.
All pregnancies have a background risk of birth defects, loss, or
other adverse outcomes. In the U.S. general population, the
estimated background risk of major birth defects and miscarriage in
clinically recognized pregnancies is 2-4% and 15-20%,
respectively.
Lactation
Risk Summary
There are no data on the presence of
fluoroestradiol F 18 in human milk, or its effects on the breastfed
infant or milk production. Lactation studies have not been
conducted in animals. Advise a lactating woman to avoid
breastfeeding for 4 hours after CERIANNA administration in order to
minimize radiation exposure to a breastfed infant.
Pediatric Use
The safety and effectiveness of CERIANNA in
pediatric patients have not been established.
Geriatric Use
Clinical studies of fluoroestradiol F 18
injection did not reveal any difference in pharmacokinetics or
biodistribution in patients aged 65 and over.
DRUG INTERACTIONS
Systemic Endocrine Therapies that Target Estrogen
Receptors
Certain classes of systemic endocrine
therapies, including ER modulators and ER down-regulators, block
ER, reduce the uptake of fluoroestradiol F 18, and may reduce
detection of ER-positive lesions after administration of CERIANNA.
Drugs from these classes such as tamoxifen and fulvestrant may
block ER for up to 8 and 28 weeks, respectively. Do not delay
indicated therapy in order to administer CERIANNA. Administer
CERIANNA prior to starting systemic endocrine therapies that block
ER.
To report SUSPECTED ADVERSE REACTIONS, contact Zionexa US Corp
at +1.844.946.6392 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
1 Mariotto et al. Estimation of the Number of Women Living with
Metastatic Breast Cancer in the United States. Cancer Epidemiology,
Biomarkers & Prevention. 2017:
10.1158/1055-9965.EPI-16-0889.
2 Survival Rates for Breast Cancer, Jan 27 2021.
https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-survival-rates.html
3 Kurland, et al. Between-patient and within-patient
(site-to-site) variability in estrogen receptor binding, measured
in vivo by 18F-fluoroestradiol PET. J Nucl Med.
2011;52(10):1541-1549 / Currin, et al. Temporal Heterogeneity of
Estrogen Receptor Expression in Bone-Dominant Breast Cancer:
18F-Fluoroestradiol PET Imaging Shows Return of ER Expression. J
Natl Compr Canc Netw. 2016;14(2):144-147
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David Morris David.J.Morris@ge.com +44 7920591370
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