Pfizer spinout SpringWorks gets FDA priority review for lead drug
A Pfizer spinout is getting a quick date with regulators for its “pipeline-in-a-product.”
SpringWorks Therapeutics announced Monday morning that the FDA granted nirogacestat, the biotech’s lead candidate, priority review for adults with desmoid tumors. Should the drug win approval, it would be the company’s first since being spun out of Pfizer five and a half years ago.
The FDA will make a decision by Aug. 27, SpringWorks said in a press release.
Monday’s news comes after nirogacestat passed a Phase III test in May 2022, achieving a 71% reduction in the risk of disease progression as a monotherapy. The primary endpoint, median progression-free survival, was not reached in the trial’s active arm, while patients in the placebo group had a median PFS of 15.1 months.
The drug also hit secondary goals of statistically significant improvements over placebo in objective response rate (41% vs. 8%) and patient-reported outcomes in the 142-person study.
Nirogacestat is an oral small molecule gamma secretase inhibitor, spun out of Pfizer in September 2017 with a handful of other early-stage programs and $103 million in backing, including from two Bain funds. Its other late-stage candidate, a MEK inhibitor known as mirdametinib, could be submitted for approval in the first half of next year, analysts say.
SpringWorks is also running several other nirogacestat trials for pediatric desmoid tumors, ovarian granulosa cell tumors and relapsed or refractory multiple myeloma in combination with a variety of BCMA monoclonal antibodies, bispecifics and antibody-drug conjugates.
Social: Saqib Islam, SpringWorks CEO
