FDA Approves SpringWorks Therapeutics' Lead Therapy As First For Subtype Of Soft Tissue Sarcomas

The FDA approved SpringWorks Therapeutics Inc's SWTX Ogsiveo (nirogacestat), an oral gamma-secretase inhibitor, for adult patients with progressing desmoid tumors who require systemic treatment.

Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.

Desmoid tumors are locally aggressive and invasive soft-tissue tumors that can lead to substantial morbidity. Desmoid tumors are noncancerous growths that occur in the connective tissue. Desmoid tumors most often occur in the abdomen, arms, and legs.

The FDA approval of Ogsiveo is based on the results from the Phase 3 DeFi trial. 

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. 

Median PFS was not reached in the Ogsiveo arm and was 15.1 months in the placebo arm. 

The confirmed objective response rate (ORR) was 41% with OGSIVEO versus 8% with placebo; the complete response rate was 7% in the Ogsiveo arm and 0% in the placebo arm. 

The median time to first response was 5.6 months with Ogsiveo and 11.1 months with placebo.

Ogsiveo will be available to order through a specialty pharmacy and specialty distributor network in the U.S. within five to ten business days. 

SpringWorks expects to file a Marketing Authorisation Application for Ogsiveo in desmoid tumors with the European Medicines Agency in the first half of 2024.

Citing TD Cowen analyst, Reuters noted U.S. sales estimate of $3 million in 2023 and $79 million in 2024 and peak sales of $544 million in 2032.

Price Action: SWTX shares are up 9.24% at $22.69 during the premarket session on the last check Tuesday.