Menarini Group's Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer

Menarini Industrie Farmaceutiche Riunite

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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