FDA Issues Complete Response Letter for Xspray Pharma's Dasynoc in CML and ALL
Key Insights
The FDA issued a Complete Response Letter (CRL) for Dasynoc, Xspray Pharma (search)'s treatment for chronic myeloid leukemia (CML) and acute lymphocytic leukemia (search) (ALL).
The FDA requests additional labeling information and pre-approval inspection details, but does not question stability or clinical data.
Dasynoc leverages Xspray’s HyNap technology, offering potential benefits such as lower dosing and co-administration with acid-reducing agents.
Xspray Pharma (search) AB has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Dasynoc, a novel treatment for chronic myeloid leukemia (CML) and acute lymphocytic leukemia (search) (ALL). The FDA's response, received July 26, 2024, indicates that while no additional clinical studies are required and submitted stability or clinical data are not in question, further information is needed regarding labeling comprehension and the pre-approval inspection conducted at the third-party manufacturing site in June 2024. This development delays the anticipated September launch of Dasynoc.
To address the FDA's concerns, Xspray Pharma (search) plans to collaborate with its third-party manufacturer to fulfill the requests related to the pre-approval inspection. The FDA has also suggested a dialogue with Xspray to refine the labeling strategy. Per Andersson, CEO of Xspray Pharma, expressed confidence in the company's ability to address these requests promptly, emphasizing the importance of Dasynoc as a new treatment option for CML patients, particularly those who require co-medication with acid-reducing agents.
Dasynoc: Addressing Unmet Needs in CML and ALL Treatment
Dasynoc is designed to improve upon existing dasatinib treatments for CML and ALL by utilizing Xspray's patented HyNap Technology. This technology allows for bioequivalence at a 30% lower dose of dasatinib, potentially reducing side effects and improving patient compliance. Furthermore, Dasynoc aims to provide more precise and predictable bioavailability, ensuring patients receive the intended therapeutic benefit. A key advantage of Dasynoc is its compatibility with acid-reducing agents (ARAs), including proton pump inhibitors (PPIs), H2 antagonists, and antacids.
The need for TKI and ARA co-administration is common in CML patients. Data presented at the American Society of Clinical Oncology showed that 54% of CML patients were prescribed a PPI despite existing warnings about potential interactions. A separate study indicated that the 5-year overall survival was reduced by 15% in patients who took both a TKI and a PPI, highlighting the clinical significance of Dasynoc's ARA compatibility.
Implications and Next Steps
While the CRL represents a setback, Xspray Pharma (search) remains committed to bringing Dasynoc to market. The company is working to address the FDA's requests and expects to provide an updated timeline for NDA resubmission in the coming weeks. The potential benefits of Dasynoc, particularly its ability to be co-administered with ARAs without compromising efficacy, could significantly improve the treatment landscape for CML and ALL patients.