The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
The totality of the evidence led the FDA to determine that the criteria for issuing an EUA had not been met.
Hospitals, pharmacies, and distributors are being asked to immediately discontinue use or distribution of the recalled product.
A phase 1 trial is currently evaluating the safety and tolerability of ADI-001 in 76 participants with B cell malignancies.
These SCS devices were cleared based on data from a randomized controlled trial published in the journal Diabetes Care in 2014.
Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
The device is attached to the top of the canister of the patient’s inhaler and works together with the mobile app to monitor and provide feedback.
Patients treated with gammaCore experienced clinically meaningful benefits.