OGSIVEO™ (nirogacestat)
FOR IMMEDIATE RELEASE:
OGSIVEO™ (nirogacestat) Now Available from Onco360 as the First and Only FDA-Approved Treatment for Adults with Progressing Desmoid Tumors Who Require Systemic Treatment
Louisville, KY — November 28, 2023 — Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by SpringWorks Therapeutics for Ogsiveo™ (nirogacestat). Ogsiveo™ is an oral gamma secretase inhibitor for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.
“Onco360 is excited to partner with the team at SpringWorks Therapeutics and become a specialty pharmacy partner for Ogsiveo™,” said Benito Fernandez, Chief Commercial Officer. “Ogsiveo™ is the first FDA-approved therapy for patients with desmoid tumors and represents an important therapeutic advancement for patients managing this rare non-cancerous genetic disorder.”
Desmoid tumors are rare yet locally aggressive and invasive soft-tissue tumors, occurring in approximately 900 to 1,500 people in the United States each year. Desmoid tumors mostly affect people between the ages of 15 and 60 years, but they can occur at any age. Desmoid tumors are more common in women than in men. In children, desmoid tumors most often occur between the ages of 15 and 16 years. Desmoid tumors often recur at or near the original tumor site after surgery. Reported recurrence rates after surgery vary widely, from approximately 20% to as high as 80%.1
The FDA approval of Ogsiveo™ is based on the results from the Phase 3 DeFi trial (NCT03785964). Patients were randomized to receive 150 mg OGSIVEO or placebo orally twice daily until disease progression or unacceptable toxicity and patients were stratified by primary tumor(s) location (intra-abdominal versus extra-abdominal). Ogsiveo™ met the primary endpoint of improving progression-free survival (PFS), demonstrating a statistically significant improvement over placebo with a 71% reduction in the risk of disease progression (hazard ratio (HR) = 0.29 (95% CI: 0.15, 0.55); p< 0.001).2
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.2
Please see the full Prescribing Information for Ogsiveo™.
Media Contact:
Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332
References:
- American Society of Clinical Oncology (ASCO). Desmoid Tumor: Statistics. Accessed November 2023. https://www.cancer.net/cancer-types/desmoid-tumor/statistics.
- Ogsiveo™ Prescribing Information. Accessed November 2023.