- Elacestrant, if approved, would be the first oral
selective estrogen receptor degrader (SERD) to be available
for patients suffering from 2L and 3L ER+/HER2- advanced or
metastatic breast cancer
- Submission supported by results from the pivotal Phase 3
EMERALD study of elacestrant showing statistically
significant efficacy over current standard-of-care (SOC)
medications for both the overall study population and patients
whose tumors harbor an ESR1 mutation
- U.S. FDA has assigned a Prescription Drug User Fee Act
(PDUFA) date of February 17,
2023
FLORENCE, Italy and
NEW YORK, NY, Aug. 11, 2022 /PRNewswire/ -- The Menarini Group
("Menarini"), a privately held Italian pharmaceutical and
diagnostics company, and Stemline Therapeutics ("Stemline"), a
wholly-owned subsidiary of Menarini Group, today announced that the
U.S. Food and Drug Administration (FDA) has accepted the Company's
New Drug Application (NDA) for elacestrant, an investigational
selective estrogen receptor degrader (SERD), for patients with
ER+/HER2- advanced or metastatic breast cancer. The FDA has granted
the application Priority Review and assigned a PDUFA date of
February 17, 2023.
The FDA grants Priority Review designation to medicines that it
considers have the potential to provide significant improvements
over current SOC in the safety and effectiveness of the treatment,
diagnosis, or prevention of serious conditions. The FDA granted
Fast Track designation for elacestrant in 2018.
"The FDA's acceptance of our NDA with Priority Review marks an
important regulatory milestone for our company," commented
Elcin Barker Ergun, Chief Executive
Officer of the Menarini Group. "We look forward to working with the
FDA during its review of this submission, which addresses a new
potential therapeutic option for a major unmet need in the
management of patients with advanced or metastatic breast cancer
after resistance builds in the earlier lines of the treatment."
The NDA submission was supported by results of the Phase 3 data
from the EMERALD study. EMERALD met both of its pre-specified
primary endpoints of progression-free survival (PFS) in the overall
population and in patients with the ESR1 mutation (mESR1)
compared to SOC endocrine monotherapy; the trial's comparator arms
were investigators' choice of either fulvestrant or an aromatase
inhibitor. The PFS rate at 12 months with elacestrant was 22.32%
vs. 9.42% with SOC in the overall population, and 26.76% vs. 8.19%
in the ESR1 mutation population. The clinical trial data
showed that elacestrant reduced the risk of disease progression or
death by 30% in all patients and by 45% in patients with
ESR1 mutation. The data also showed a manageable safety
profile.
Elacestrant is an investigational compound and is not approved
by any regulatory authorities. The Marketing Authorization
Application (MAA) has also been submitted to European Medicines
Agency (EMA) in July 2022. More
information about clinical trials with elacestrant is available at
www.clinicaltrials.gov.
The Menarini Group obtained global licensing rights for
elacestrant in July 2020 from Radius
Health, Inc (NASDAQ: RDUS), who conducted and successfully
completed the EMERALD study. Based on the positive phase 3 data,
Stemline, with the support of Radius, submitted a New Drug
Application (NDA) in June 2022 to the
FDA. The Menarini Group is now fully responsible for global
registration, commercialization and further development activities
for elacestrant. Stemline, headquartered in New York City, will commercialize elacestrant
if approved by the FDA. Stemline is focused on bringing
transformational oncology treatments to cancer patients, and
currently commercializes a novel targeted treatment for patients
with blastic plasmacytoid dendritic cell neoplasm in both
the United States and Europe.
About Elacestrant (RAD1901) and the EMERALD Phase 3
Study
Elacestrant is an investigational selective estrogen receptor
degrader (SERD), which is being evaluated for potential use as a
once-daily oral treatment in patients with ER+/ HER2- advanced or
metastatic breast cancer. In 2018, elacestrant received Fast Track
designation from the FDA. Preclinical studies completed prior to
EMERALD indicate that the compound has the potential for use as a
single agent or in combination with other therapies for the
treatment of breast cancer. The EMERALD Phase 3 trial is a
randomized, open label, active-controlled study evaluating
elacestrant as second- or third-line monotherapy in ER+/HER2-
advanced/metastatic breast cancer patients. The study enrolled 477
patients who had received prior treatment with one or two lines of
endocrine therapy, including a CDK 4/6 inhibitor. Patients in the
study were randomized to receive either elacestrant or the
investigator's choice of an approved hormonal agent. The primary
endpoint of the study was progression-free survival (PFS) in the
overall patient population and in patients with estrogen receptor 1
gene (ESR1) mutations. Secondary endpoints included
evaluation of overall survival (OS), objective response rate (ORR),
and duration of response (DOR).
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and
diagnostics company, with a turnover of $4
billion and over 17,000 employees. Menarini is focused on
therapeutic areas with high unmet needs with products for
cardiology, oncology, pneumology, gastroenterology, infectious
diseases, diabetology, inflammation, and analgesia. With 18
production sites and 9 Research and Development centers, Menarini's
products are available in 140 countries worldwide. For further
information, please visit www.menarini.com.
About Radius
Radius is a global biopharmaceutical company focused on
addressing unmet medical needs in the areas of bone health, neuro-
orphan diseases, and oncology. Radius' lead product, TYMLOS®
(abaloparatide) injection, was approved by the U.S. Food and Drug
Administration for the treatment of postmenopausal women with
osteoporosis at high risk for fracture. The Radius clinical
pipeline includes investigational abaloparatide injection for
potential use in the treatment of men with osteoporosis; the
investigational drug, elacestrant (RAD1901), for potential use in
the treatment of hormone-receptor positive breast cancer
out-licensed to Menarini Group; and the investigational drug
RAD011, a synthetic cannabidiol oral solution with potential
utilization in multiple neuro-endocrine, neurodevelopmental, or
neuropsychiatric disease areas, initially targeting Prader-Willi
syndrome, Angelman syndrome, and infantile spasms.
Logo:
https://mma.prnewswire.com/media/1876570/MENARINI_GROUP.jpg