Palvella SELVA Trial Delivers +2.13 mLM-IGA Gain, 95% Response; NDA Due H2 2026
In Phase 3 SELVA study of 49 patients ≥6, QTORIN gel showed a +2.13 mean mLM-IGA improvement (p<0.001) and significance on all secondary endpoints. 95% improved and 86% rated much or very much improved at Week 24; no drug-related SAEs, NDA planned H2 2026.
1. Phase 3 SELVA Trial Results
Palvella’s Phase 3 SELVA study enrolled 49 patients aged ≥6 with microcystic lymphatic malformations and achieved a mean mLM-IGA improvement of +2.13 (p<0.001). All four prespecified secondary efficacy endpoints also reached statistical significance (all p<0.001).
2. Patient Response and Safety
At Week 24, 95% of participants improved on the mLM-IGA and 86% were rated as “Much Improved” or “Very Much Improved”. QTORIN rapamycin was well-tolerated with no drug-related serious adverse events and systemic rapamycin levels remained below 2 ng/mL in all subjects.
3. Regulatory Pathway and Market Potential
Palvella plans to submit a New Drug Application for QTORIN rapamycin in the second half of 2026, targeting potential FDA approval in the first half of 2027. If approved, QTORIN could become the first standard-of-care therapy for over 30,000 U.S. patients with microcystic lymphatic malformations.