Written By: Abhinay Wadekar BPharm
Reviewed By: Pharmacally Editorial Team
Xspray Pharma recently received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning its New Drug Application (NDA) for Dasynoc (dasatinib) a promising treatment for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). This regulatory setback was primarily triggered by manufacturing quality issues identified at a third-party contract manufacturing organization (CMO), resulting in the FDA pausing the approval process until these Good Manufacturing Practice (GMP) concerns are satisfactorily addressed.
About Dasynoc and Its Clinical Significance
Dasynoc is an innovative reformulation of dasatinib, a tyrosine kinase inhibitor widely used to treat CML and ALL. Unlike traditional dasatinib formulations, Dasynoc offers a 30% lower dose due to its improved solubility and enhanced bioavailability. Moreover, it is designed to be compatible with proton pump inhibitors (PPIs), which are commonly prescribed alongside cancer therapies but often interfere with standard dasatinib absorption. This novel formulation potentially decreases drug-drug interactions, offering a safer and more effective treatment option for patients battling these hematologic malignancies.
The FDA’s Complete Response Letter: GMP Concerns
The FDA’s CRL, dated October 2025, highlights manufacturing deficiencies at the contract manufacturer responsible for parts of Dasynoc’s production. Even though the issues are linked to the manufacturer’s broader facility operations rather than the specific production line used for Dasynoc, the concerns fall under GMP non-compliance. These deficiencies have delayed FDA approval, with the agency requiring the manufacturer to implement corrective measures before the drug can receive market authorization.
This marks the third occasion Dasynoc has faced a CRL, with prior letters issued in July 2023 and July 2024 requesting additional clinical data and site inspections. The current CRL specifically emphasizes manufacturing process improvements and demands evidence demonstrating the product’s quality and labeling accuracy.
Xspray Pharma’s Response
Xspray Pharma has responded proactively, confirming that the contract manufacturer is undertaking a comprehensive remediation plan to resolve the FDA’s observations. The company has scheduled a key meeting with the FDA in December 2025 to discuss the corrective actions and to chart out a path forward for Dasynoc’s approval. Additionally, Xspray is preparing to submit further data affirming the safety, efficacy, and accurate labeling of Dasynoc.
Despite these setbacks, Xspray remains committed to bringing Dasynoc to market, underscored by its receipt of orphan drug designation from the FDA since 2022. This designation highlights Dasynoc’s importance as a treatment for rare cancers, granting Xspray certain regulatory incentives to support drug development and approval.
Dasynoc represents a promising advancement over existing therapies for CML and ALL. The company’s efforts to meet FDA standards and resolve manufacturing issues are critical to ensuring that patients receive safe, high-quality medication.
References
Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval, Xspray Pharma, 08 Oct 2025, https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-provides-update-on-the-fda-process-for-dasynoc-observations-at-contract-manufacturer-delay-approval/