Desmoid Tumor Treatments
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Brand Name
Ogsiveo
Generic Name
Nirogacestat
View Brand Information FDA approval date: November 27, 2023
Classification: Gamma Secretase Inhibitor
Form: Tablet
What is Ogsiveo (Nirogacestat)?
OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment.
Approved To Treat
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Brand Information
OGSIVEO (nirogacestat)
1INDICATIONS AND USAGE
OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.
2DOSAGE FORMS AND STRENGTHS
The 100 mg tablets are round, light orange, film-coated, and debossed with “100” on one face. Each 100 mg tablet contains 100 mg nirogacestat.
The 150 mg tablets are oval, yellow orange, film-coated, and debossed with “150” on one face. Each 150 mg tablet contains 150 mg nirogacestat
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Diarrhea
- Ovarian Toxicity
- Hepatotoxicity
- Non-Melanoma Skin Cancers
- Electrolyte Abnormalities
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 OGSIVEO was evaluated in 69 patients enrolled in DeFi with progressing desmoid tumor
Serious adverse reactions occurred in 20% of patients who received OGSIVEO. Serious adverse reactions occurring in ≥ 2% of patients were ovarian toxicity (4%).
Permanent discontinuation of OGSIVEO due to an adverse reaction occurred in 20% of patients. Adverse reactions which resulted in permanent discontinuation of OGSIVEO in ≥ 2% of patients were diarrhea, ovarian toxicity, increased ALT, and increased AST.
Dosage interruptions of OGSIVEO due to an adverse reaction occurred in 51% of patients. Adverse reactions which required dosage interruption in ≥ 2% of patients included diarrhea, rash, stomatitis, hypophosphatemia, fatigue, folliculitis, nausea, and ovarian toxicity.
Dose reductions of OGSIVEO due to an adverse reaction occurred in 42% of patients. Adverse reactions which required dose reductions in ≥ 2% of patients included diarrhea, rash, stomatitis, hypophosphatemia, folliculitis, hidradenitis, and ovarian toxicity.
The most common (≥ 15% with a difference between arms of ≥ 5% compared to placebo) adverse reactions that occurred in patients receiving OGSIVEO were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea.
Table 2 summarizes the adverse reactions that occurred in DeFi.
aIncludes multiple related composite terms.
b Investigator assessment of ovarian toxicity included ovarian failure, premature menopause, amenorrhea, and menopause
cThe number of females of reproductive potential in each arm is used as the denominator (OGSIVEO N = 36, Placebo N = 37).
Clinically relevant adverse reactions occurring in < 15% of patients receiving OGSIVEO in DeFi included non-melanoma skin cancers, epistaxis, hidradenitis suppurativa, folliculitis, influenza-like illness, and renal tubular disorder.
Table 3 summarizes laboratory abnormalities in DeFi.
aThe denominator used to calculate the rate was 69 for nirogacestat and 72 for placebo based on the number of patients with a baseline value and at least one post-treatment value.
bCTCAE Version 5.0 does not include numeric thresholds for grading of hypophosphatemia; all grades represent patients with lab value < Lower Limit of Normal (LLN).
cThe denominator used to calculate the rate was 68 for nirogacestat and 69 for placebo based on the number of patients with a baseline value and at least one post-treatment value.
dCTCAE Version 5.0 does not include numeric thresholds for grading of increased urine glucose.
5OVERDOSAGE
Due to the high level of protein binding, OGSIVEO is not expected to be dialyzable
6DESCRIPTION
OGSIVEO oral tablets contain nirogacestat (as nirogacestat hydrobromide), a gamma (ɣ) secretase inhibitor. Nirogacestat hydrobromide is chemically known as (S)-2-(((S)-6,8-Difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl) pentanamide dihydrobromide. The empirical formula is C
OGSIVEO (nirogacestat) tablets are immediate release (IR), film-coated tablets intended for oral administration. Each 100 mg tablet contains 100 mg nirogacestat as 133.050 mg nirogacestat hydrobromide. OGSIVEO 100 mg tablets are round, biconvex with an approximate diameter of 10 mm. They are film coated, light orange in color, and debossed with “100” on one face and plain on the other face. Each 150 mg tablet contains 150 mg nirogacestat as 199.574 mg nirogacestat hydrobromide. OGSIVEO 150 mg tablets are oval, biconvex with approximate dimensions of 8.5 × 17.5 mm. They are film coated, yellow orange in color, and debossed with “150” on one face and plain on the other face.
OGSIVEO tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate type A. The tablets are finished with Opadry
7HOW SUPPLIED/STORAGE AND HANDLING
OGSIVEO (nirogacestat) is supplied as 100 mg and 150 mg tablets. Each 100 mg light orange, film-coated tablet is debossed with a “100” on one face. Each 150 mg yellow orange, film-coated tablet is debossed with a “150” on one face.
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Diarrhea
Advise patients that OGSIVEO can cause diarrhea, which may be severe, and to contact their healthcare provider for sustained diarrhea that does not respond to supportive care
Ovarian Toxicity
Advise females of reproductive potential that OGSIVEO can cause ovarian toxicity and impair fertility, and that these effects may continue following discontinuation of OGSIVEO. Advise patients to tell their healthcare provider if they experience symptoms of ovarian toxicity, including hot flashes or menstrual irregularities
Liver Toxicity
Advise patients that OGSIVEO can cause ALT or AST elevations, and that their healthcare provider should monitor liver transaminase levels regularly
Non-Melanoma Skin Cancers
Advise patients that OGSIVEO can cause new non-melanoma skin cancers, that they will be monitored for these, and to contact their healthcare provider for any new or changing lesions on their skin
Electrolyte Abnormalities
Advise patients that OGSIVEO can cause hypophosphatemia and/or hypokalemia which may require phosphate and/or potassium supplementation. Advise patients that they will be monitored for these and to contact their healthcare provider if they experience muscle pain or weakness
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential harm to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy, and to stop taking OGSIVEO if they become pregnant. Advise females of reproductive potential to use effective contraception during treatment with OGSIVEO and for 1 week after the last dose
Lactation
Advise women not to breastfeed during treatment with OGSIVEO and for 1 week after the last dose
Drug Interactions
Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Inform patients to avoid starfruit, Seville oranges, grapefruit, and juice from any of these fruits when taking OGSIVEO
Manufactured for:
SpringWorks Therapeutics, Inc. Stamford, CT 06902
OGSIVEO
©2026 SpringWorks Therapeutics, Inc.
9PRINCIPAL DISPLAY PANEL
NDC 82448-100-14
10PRINCIPAL DISPLAY PANEL
NDC 82448-150-14
