Video Library

Learn about unique perspectives and experiences with desmoid tumors and OGSIVEO.

Unmet Need

Watch Dr. Federman and Dr. Randall discuss the burden of desmoid tumors, patient characteristics, signs of disease progression, and management considerations.

“[Desmoid tumors] can cause a lot of problems. So, we as physicians, need to really listen to our patients and their journey thus far when they come to see us. Are their symptoms getting worse? Is the tumor growing based on objective criteria like MRI or CT, is it impairing their function?”

Dr. Randall, M.D., FACS, Professor and Chair, Department of Orthopedic Surgery,
University of California, Davis School of Medicine

Review the OGSIVEO Overview for Healthcare Professionals for a summary of information about OGSIVEO, including clinical data, guideline recommendations, and information about adverse events.

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OGSIVEO Overview and Patient Case Study

Watch Dr. Federman and Dr. Randall discuss the DeFi trial design, review efficacy and safety results, and present a hypothetical case study of a patient treated with OGSIVEO.

“The route of entry into the health care system is often through orthopedic surgeons and surgical oncologists and sometimes general community surgeons. And so, this is where it’s really important that these patients are presented, in a multidisciplinary format and that there are real experts at the table that have seen these patients before.”

Dr. Noah Federman, M.D. Medical Director, Clinical Translational Research Center Director, Pediatric Bone and Soft Tissue Program, UCLA Los Angeles, California

Review the OGSIVEO Overview for Healthcare Professionals for a summary of information about OGSIVEO, including clinical data, guideline recommendations, and information about adverse events.

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Insights from a patient, oncologist, and pharmacist

Hear from Leif, a desmoid tumor patient, as he discusses his journey, from initial diagnosis to finding a treatment approach that works for him. He’s joined by his medical oncologist, Dr. Fade Mahmoud, and clinical pharmacist, Alexis Spence, who share their experiences and role in treating patients like Leif as part of a multidisciplinary care team.

“When I started on OGSIVEO, me and Dr. Mahmoud had talked about a care plan. And at the three-month mark, we had done blood work, and did an MRI and noticed that the tumor was starting to reduce in size at that point. And then at the six-month mark, we had noticed we were probably 50% smaller than when we had started. The tumor’s very minimal at this point.”

Leif, a patient taking OGSIVEO

This video represents the personal experience of Leif only. Individual results may vary.

Review the OGSIVEO Overview for Healthcare Professionals for a summary of information about OGSIVEO, including clinical data, guideline recommendations, and information about adverse events.

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Download the DeFi Study Publication

OGSIVEO was evaluated in DeFi—the largest completed Phase 3 trial of an FDA-approved therapy in adult patients with desmoid tumors. Review the results of this landmark study in The New England Journal of Medicine.

Patient Profiles

Explore hypothetical patient profiles to learn about examples of progressing desmoid tumors and when treatment with OGSIVEO may be appropriate.

Request a Rep

Learn more about OGSIVEO support by speaking with a SpringWorks representative.

Indication
Important Safety Information

Indication 

OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.

Important Safety Information

Warnings And Precautions

Diarrhea: Diarrhea, sometimes severe, can occur in patients treated with OGSIVEO. Diarrhea occurred in 84% of patients treated with OGSIVEO, and included Grade 3 events in 16% of patients. Median time to first diarrhea event was 9 days (range: 2 to 434 days). Monitor patients and manage using antidiarrheal medications. Modify dose as recommended.

Ovarian Toxicity: Female reproductive function and fertility may be impaired in patients treated with OGSIVEO. Impact on fertility may depend on factors like duration of therapy and state of gonadal function at time of treatment. Long-term effects of OGSIVEO on fertility have not been established. Advise patients on the potential risks for ovarian toxicity before initiating treatment. Monitor patients for changes in menstrual cycle regularity or the development of symptoms of estrogen deficiency, including hot flashes, night sweats, and vaginal dryness.

Hepatotoxicity: ALT or AST elevations occurred in 30% and 33% of patients, respectively. Grade 3 ALT or AST elevations (>5 x ULN) occurred in 6% and 2.9% of patients. Monitor liver function tests regularly and modify dose as recommended.

Non-Melanoma Skin Cancers: New cutaneous squamous cell carcinoma and basal cell carcinoma occurred in 2.9% and 1.4% of patients, respectively. Perform dermatologic evaluations prior to initiation of OGSIVEO and routinely during treatment.

Electrolyte Abnormalities: Decreased phosphate (65%) and potassium (22%) occurred in OGSIVEO-treated patients. Phosphate <2 mg/dL occurred in 20% of patients. Grade 3 decreased potassium occurred in 1.4% of patients. Monitor phosphate and potassium levels regularly and supplement as necessary. Modify dose as recommended.

Embryo-Fetal Toxicity: OGSIVEO can cause fetal harm when administered to pregnant women. Oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity and death at maternal exposures below human exposure at the recommended dose of 150 mg twice daily. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during treatment with OGSIVEO and for 1 week after the last dose.

Adverse Reactions

The most common (≥15%) adverse reactions were diarrhea (84%), ovarian toxicity (75% in the 36 females of reproductive potential), rash (68%), nausea (54%), fatigue (54%), stomatitis (39%), headache (30%), abdominal pain (22%), cough (20%), alopecia (19%), upper respiratory tract infection (17%), and dyspnea (16%).

Serious adverse reactions occurred in 20% of patients who received OGSIVEO. Serious adverse reactions occurring in ≥2% of patients were ovarian toxicity (4%).

The most common laboratory abnormalities (≥15%) were decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium.

Drug Interactions

CYP3A Inhibitors and Inducers: Avoid concomitant use with strong or moderate CYP3A inhibitors (including grapefruit products, Seville oranges, and starfruit) and strong or moderate CYP3A inducers.

Gastric Acid Reducing Agents: Avoid concomitant use with proton pump inhibitors and H2 blockers. If concomitant use cannot be avoided, OGSIVEO can be staggered with antacids (e.g., administer OGSIVEO 2 hours before or 2 hours after antacid use).

Consult the full Prescribing Information prior to and during treatment for important drug interactions.

Use in Specific Populations

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with OGSIVEO and for 1 week after the last dose.

OGSIVEO may reduce the effectiveness of hormonal contraceptives. Addition of a barrier method is recommended for females using hormonal contraceptives.

Please click here for full Prescribing Information.

Indication 

OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.

Please click here for full Prescribing Information.