SpringWorks Therapeutics, Inc. (NASDAQ: SWTX) experienced a notable uptick of 16.03%, reaching $24.10 in the extended trading session on Monday. This recovery not only nullified the regular-session decline of 4.51% but also culminated in a closing figure of $20.77. The surge in SWTX stock value ensued subsequent to a momentous regulatory approval.
SpringWorks (SWTX) disclosed that the U.S. Food and Drug Administration (FDA) has sanctioned OGSIVEO (nirogacestat), an oral gamma secretase inhibitor. This approval is specifically designated for the treatment of adult patients grappling with advancing desmoid tumors necessitating systemic intervention. Nirogacestat had previously garnered breakthrough therapy, fast track, and orphan drug designations from the FDA for desmoid tumor treatment.
Marking a significant milestone, SpringWorks has introduced the inaugural FDA-approved therapeutic solution for individuals contending with desmoid tumors. This development addresses a longstanding need within the community for an efficacious intervention capable of not only reducing tumor size but also markedly ameliorating pain—the most debilitating symptom encountered by individuals afflicted with desmoid tumors.
The impact of desmoid tumors on individuals’ lives is considerable, compounded by their invasive nature and a high proclivity for recurrence. OGSIVEO emerges as a pioneering therapeutic approach, supported by efficacy data showcasing substantial antitumor activity and a pronounced enhancement in desmoid tumor symptoms.
The green light for OGSIVEO from the FDA is rooted in the outcomes of the Phase 3 DeFi trial, which featured in the March 9, 2023, edition of the New England Journal of Medicine. OGSIVEO successfully met the primary endpoint of enhancing progression-free survival (PFS), demonstrating a statistically significant 71% reduction in the risk of disease progression compared to the placebo.
The improvements in PFS and overall response rate (ORR) favored OGSIVEO across various baseline characteristics, including sex, tumor location, tumor focality, treatment history, prior interventions, mutational status, and familial adenomatous polyposis history.
Furthermore, OGSIVEO showcased early and sustained enhancements in patient-reported outcomes (PROs), encompassing pain, desmoid tumor-specific symptoms, physical/role functioning, and overall health-related quality of life.
