Palvella Announces FDA Acceptance and Priority Review of QTORIN™ Rapamycin NDA; February 28, 2027 PDUFA Target Action Date Set
The FDA accepted and granted Priority Review to Palvella's NDA for QTORIN rapamycin in microcystic lymphatic malformations, with a PDUFA target action date of February 28, 2027. The application rests on the Phase 3 SELVA study, which hit statistical significance on all six prespecified endpoints (p<0.001), with 95% of evaluated participants improving on the primary endpoint. If approved, QTORIN rapamycin would be the first FDA-approved therapy for the estimated 30,000+ diagnosed U.S.
Key figures
- Drug Name
- QTORIN 3.9% rapamycin anhydrous gel
- Pdufa date
- February 28, 2027
- Review type
- Priority Review
- Launch timing
- first half of 2027
- Addressable patients us
- more than 30,000
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