Research & Development
SpringWorks Therapeutics' Ogsiveo tablets receive US FDA approval
28 November 2023 -

SpringWorks Therapeutics Inc, a United States-based drug company that develops therapeutic medicines for various diseases, announced on Monday that it has received approval from the US Food and Drug Administration for its Ogsiveo (nirogacestat) tablets intended for adult patients with progressing desmoid tumours who require systemic treatment.

Ogsiveo's effectiveness was assessed in an international, multicentre, randomised, double-blind, placebo-controlled trial in 142 adult subjects with progressing desmoid tumours not amenable to surgery. Subjects were randomised to receive 150 milligrams (mg) of the product or placebo orally, twice daily, until disease progression or unacceptable toxicity.

The main efficacy result measure was progression-free survival, and objective response rate was an additional efficacy result measure.

The pivotal clinical trial demonstrated that the product provided a clinically meaningful and statistically significant improvement in progression-free survival compared to placebo. The objective response rate was also statistically different between the two arms, with a response rate of 41 percent in the Ogsiveo arm and 8 percent in the placebo arm. The progression-free survival outcome was also supported by an evaluation of patient-reported pain favouring the Ogsiveo arm.