Menarini Group's Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer
PR97413
FLORENCE, Italy and NEW YORK, August 11, 2022 /PRNewswire=KYODO JBN/ --
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
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
[https://ascopubs.org/doi/full/10.1200/JCO.22.00338 ] 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.
SOURCE: Menarini Industrie Farmaceutiche Riunite
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