Brand Name
Orserdu
Generic Name
ELacestrant
View Brand Information FDA approval date: January 27, 2023
Classification: Estrogen Receptor Antagonist
Form: Tablet
What is Orserdu (ELacestrant)?
ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor -positive, human epidermal growth factor receptor 2 ‑negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. ORSERDU is an estrogen receptor antagonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
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Brand Information
ORSERDU (Elacestrant)
1INDICATIONS AND USAGE
ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative,
2DOSAGE FORMS AND STRENGTHS
Tablets: Elacestrant 345 mg (equivalent to 400 mg elacestrant hydrochloride) and 86 mg (equivalent to 100 mg elacestrant hydrochloride):
- 345 mg: light blue, unscored, oval film-coated biconvex tablet, imprinted with “MH” on one side and plain on the other side.
- 86 mg: light blue, unscored, round film-coated biconvex tablet, imprinted with “ME” on one side and plain on the other side.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Dyslipidemia
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ORSERDU was evaluated in 467 patients with ER+/HER2- advanced breast cancer following CDK4/6 inhibitor therapy in EMERALD, a randomized, open-label, multicenter study
Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
Permanent discontinuation of ORSERDU due to an adverse reaction occurred in 6% of patients. Adverse reactions which resulted in permanent discontinuation of ORSERDU in >1% of patients were musculoskeletal pain (1.7%) and nausea (1.3%).
Dosage interruptions of ORSERDU due to an adverse reaction occurred in 15% of patients. Adverse reactions which resulted in dosage interruption of ORSERDU in >1% of patients were nausea (3.4%), musculoskeletal pain (1.7%), and increased ALT (1.3%).
Dosage reductions of ORSERDU due to an adverse reaction occurred in 3% of patients. Adverse reactions which required dosage reductions of ORSERDU in >1% of patients were nausea (1.7%).
The most common (≥10%) adverse reactions, including laboratory abnormalities, of ORSERDU were musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia.
Table 3 summarizes the adverse reactions in EMERALD.
Table 3: Adverse Reactions (>10%) in Patients with ER-positive, HER2-negative, Advanced or Metastatic Breast Cancer Who Received ORSERDU in EMERALD
Clinically relevant adverse reactions in < 10% of patients who received ORSERDU included rash, insomnia, dyspnea, cough, dizziness, stomatitis and gastroesophageal reflux disease.
Table 4 summarizes the laboratory abnormalities in EMERALD.
Table 4: Select Laboratory Abnormalities (>10%) That Worsened from Baseline in Patients with ER-positive, HER2-negative, Advanced or Metastatic Breast Cancer Who Received ORSERDU in EMERALD
5DESCRIPTION
Elacestrant hydrochloride is the salt form of elacestrant, an estrogen receptor antagonist, that has the chemical name: (6R)-6-(2-(N-(4-(2-(ethylamino)ethyl)benzyl)-N-ethylamino)-4-methoxyphenyl)-5,6,7,8-tetrahydronaphthalen-2-ol dihydrochloride. Elacestrant hydrochloride is the dihydrochloride salt and the molecular formula is C
Elacestrant hydrochloride is a white to off-white to grey solid and is freely soluble in 0.01N HCI.
ORSERDU (elacestrant) 345 mg film-coated tablet contains 400 mg of elacestrant hydrochloride (approximately 345 mg of elacestrant free base).
ORSERDU (elacestrant) 86 mg film-coated tablet contains 100 mg of elacestrant hydrochloride (approximately 86 mg of elacestrant free base).
Both tablet strengths contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate (non-bovine), microcrystalline cellulose, and silicified microcrystalline cellulose. The tablets also contain Opadry II Blue (polyvinyl alcohol, titanium dioxide, polyethylene glycol, FD&C Blue #1 and talc).
6CLINICAL STUDIES
The efficacy of ORSERDU was evaluated in EMERALD (NCT03778931), a randomized, open-label, active-controlled, multicenter trial that enrolled 478 postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer of which 228 patients had
Patients were randomized (1:1) to receive ORSERDU 345 mg orally once daily (n=239), or investigator’s choice of endocrine therapy (n=239), which included fulvestrant (n=166), or an aromatase inhibitor (n=73; anastrozole, letrozole or exemestane). Randomization was stratified by
The major efficacy outcome was progression-free survival (PFS), assessed by a blinded imaging review committee (BIRC). An additional efficacy outcome measure was overall survival (OS).
A statistically significant difference in PFS was observed in the intention to treat (ITT) population and in the subgroup of patients with
Among the patients with
Efficacy results are presented in
Table 7: Efficacy Results for EMERALD (Patients with
Figure 1: Kaplan-Meier Curve for PFS in EMERALD (Patients with
+ Censored times
7HOW SUPPLIED/STORAGE AND HANDLING
ORSERDU (elacestrant) film-coated tablets for oral use are supplied as follows:
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Dyslipidemia
Advise patients that hypercholesterolemia and hypertriglyceridemia may occur while taking ORSERDU. Inform patients that lipid profile monitoring will be performed prior to starting and periodically while taking ORSERDU
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy
Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose
Lactation
Advise women not to breastfeed during treatment with ORSERDU and for 1 week after the last dose
Infertility
Advise males and females of reproductive potential that ORSERDU may impair fertility
Drug Interactions
Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, and herbal products
Other Common Adverse Reactions
Advise patients that other adverse reactions with ORSERDU treatment may include musculoskeletal pain, nausea, fatigue, vomiting, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia,
Dosing Instructions
Instruct patients to take ORSERDU at approximately the same time each day and to swallow the tablet(s) whole. Tablets should not be chewed, crushed, or split prior to swallowing
Advise patients to take ORSERDU with food to reduce nausea and vomiting
Instruct patients that if a dose of ORSERDU is missed for more than 6 hours or vomiting occurs, skip the dose and take the next dose the following day at its regularly scheduled time
ORSERDU is a trademark of the Menarini Group.
9PRINCIPAL DISPLAY PANEL - NDC:72187-0101-3 - Orserdu Bottle Label - 86mg
NDC 72187-0101-3
Orserdu
86 mg
Rx Only
30 Tablets
10PRINCIPAL DISPLAY PANEL - NDC: 72187-0102-3 - Orserdu Bottle Label - 345mg
NDC 72187-0102-3
Orserdu
345 mg
Rx Only
30 Tablets
