Xspray Pharma has received a Complete Response Letter (CRL) from the FDA in response to its NDA for Dasynoc (dasatinib) — which treats chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) — due to CMO issues related to Good Manufacturing Practices (GMP).
No observations were directed at the production line used for Dasynoc, but the FDA is pausing approvals of new products at the third party facility while corrective actions are being implemented. The CMO 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.”
This is the second CRL for Dasynoc. The first, which it received in July 2024, requested additional information about labeling comprehension and pre-approval from the third party’s manufacturing site. Now, 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.