FDA Grants Rolling Review of Palvella’s QTORIN™ Rapamycin NDA for Microcystic Lymphatic Malformations
The FDA has granted rolling review for Palvella’s New Drug Application for QTORIN™ rapamycin, targeting microcystic lymphatic malformations. This regulatory mechanism allows the FDA to review completed sections of the application as they are submitted, facilitating an expedited process while Palvella targets completion of the full NDA in the second half of 2026. The therapy holds Breakthrough Therapy, Orphan Drug and Fast Track designations and aims to serve the more than 30,000 individuals in the U.S.
Key figures
- Drug Name
- QTORIN™ rapamycin
- Submission timing
- second half of 2026
- Addressable population us
- more than 30,000
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