The FDA is expected to decide on QTORIN rapamycin for Microcystic lymphatic malformations by February 28, 2027, under an NDA from Palvella Therapeutics.
What the FDA is deciding on QTORIN rapamycin for Microcystic lymphatic malformations
The FDA is reviewing Palvella Therapeutics' application to approve QTORIN rapamycin (3.9% rapamycin anhydrous gel) for microcystic lymphatic malformations.
A rapamycin gel applied to the skin, under Priority Review with Breakthrough Therapy, Fast Track and Orphan Drug designations. Palvella says it would be the first FDA-approved treatment for microcystic lymphatic malformations, a lifelong condition that causes leaking, bleeding and repeat infections. In the Phase 3 SELVA study all 6 prespecified efficacy endpoints were statistically significant (all p<0.001), and Palvella reported no drug-related serious side effects and blood rapamycin levels below 2ng/mL at every measured timepoint. Palvella announced the acceptance on October 28, 2026.
What an approval or a rejection of QTORIN rapamycin would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Frequently asked questions
When will the FDA decide on QTORIN rapamycin?
The FDA's target date (PDUFA date) for QTORIN rapamycin in Microcystic lymphatic malformations is February 28, 2027.
Who disclosed it: Palvella Therapeutics. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
What is QTORIN rapamycin being reviewed for?
Palvella Therapeutics submitted an NDA for QTORIN rapamycin in Microcystic lymphatic malformations.
What to know: A rapamycin gel applied to the skin, under Priority Review with Breakthrough Therapy, Fast Track and Orphan Drug designations. Palvella says it would be the first FDA-approved treatment for microcystic lymphatic malformations, a lifelong condition that causes leaking, bleeding and repeat infections. In the Phase 3 SELVA study all 6 prespecified efficacy endpoints were statistically significant (all p<0.001), and Palvella reported no drug-related serious side effects and blood rapamycin levels below 2ng/mL at every measured timepoint. Palvella announced the acceptance on October 28, 2026.
How much will QTORIN rapamycin cost?
Palvella Therapeutics has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the QTORIN rapamycin decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Palvella press release, October 28, 2026. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.