Xspray Pharma's new drug application (NDA) for Dasynoc (dasatinib), developed for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), was recently delayed by the FDA due to manufacturing issues at the company’s contract manufacturer128.
The FDA issued a Complete Response Letter (CRL) citing Good Manufacturing Practice (GMP) observations at the facility; however, none of the concerns were directed at the specific production line used for Dasynoc153.
Because of these issues, the FDA is pausing new product approvals from the facility until corrective actions are fully implemented15.
Xspray's contract manufacturer has a remediation plan in place and a meeting with the FDA is scheduled for December to address the GMP-related deficiencies15.
Xspray and its manufacturer are actively working to resolve the issues, aiming for a swift resubmission of the NDA once corrections are made25.
No efficacy or safety concerns regarding Dasynoc itself were cited; the FDA delay is solely related to manufacturing and facility compliance135.
Dasynoc is an amorphous, lower-dose, bioequivalent formulation of dasatinib, compatible with proton pump inhibitors, targeting improved treatment options for CML and ALL patients23.
Xspray expects to resubmit the NDA and is continuing its other drug development programs as planned. The FDA has set a new PDUFA (decision) date for Dasynoc in October 20254.
Sources:
1. https://maestrodatabase.com/blog/xspray-pharma-provides-update-on-the-fda-process-for-dasynoc---observations-at-contract-manufacturer-delay-approval
2. https://www.tipranks.com/news/company-announcements/xspray-pharma-faces-fda-approval-delay-for-dasynoc-due-to-manufacturing-issues
3. https://trial.medpath.com/news/fa28a56d28060965/fda-issues-complete-response-letter-for-xspray-pharma-s-dasynoc-citing-manufacturing-issues
4. https://trial.medpath.com/news/680a1914e3225d6a/fda-sets-october-2025-pdufa-date-for-xspray-pharma-s-resubmitted-dasynoc-application
5. https://xspraypharma.com/modularfinancepressmeddelande/xspray-pharma-provides-update-on-the-fda-process-for-dasynoc-observations-at-contract-manufacturer-delay-approval/