Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval

On October 8, 2025 Xspray Pharma reported to have received a CRL from the U.S. Food and Drug Administration (FDA) concerning the Company’s New Drug Application (NDA) for Dasynoc (dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) (Press release, Xspray, OCT 8, 2025, https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-provides-update-on-the-fda-process-for-dasynoc-observations-at-contract-manufacturer-delay-approval/ [SID1234656517]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FDA’s decision is based on GMP (Good Manufacturing Practice) observations at the Company’s contract manufacturer. No observations were directed at the production line used for Dasynoc, but the FDA is pausing approvals of new products at the facility while corrective actions are being implemented. The manufacturer has confirmed that a remediation plan is already in place and that a meeting with the FDA is scheduled for December.

"It is unfortunate that manufacturing-related issues beyond our control are delaying our launch. We have made significant progress in the regulatory review and maintained discussions with the FDA regarding the product information for Dasynoc up to the PDUFA date," said Per Andersson, CEO of Xspray Pharma. "We will now work closely with both the manufacturer and the FDA to expedite the process and enable a resubmission as soon as the corrective actions have been completed."

The FDA has also requested information demonstrating that the discussed product information is appropriate and data confirming the outcome of previously implemented corrective actions at the production line.

Other programs
Xspray’s other development programs are progressing according to plan. The review of the NDA for XS003 (nilotinib) is expected to be initiated by the FDA shortly, with an anticipated PDUFA date in June 2026.