Xspray Pharma, the developer of the drug dasatinib, was recently issued a Complete Response Letter (CRL) by the FDA while waiting for corrective actions, according to Cancer Network. Based on observations termed Good Manufacturing Practice observations, the FDA elected to provide a CRL while waiting for corrective actions. The FDA is halting all approvals pending corrective actions. A remediation is scheduled as well as a meeting with the FDA in December 2025.
Xspray Pharma’s CEO, Per Andersson, gave assurances that the Company will work closely with the manufacturer and the FDA to bring about a resubmission once all corrective steps are complete.
Dasatinib has a unique process that allows patients to be given more accurate doses as it is dosed 30% lower and can be prescribed along with any acid reducing drug.
A Brief History and The First Notification
Xspray received its first CRL from the FDA in July of 2024. The CRL was based on Xspray’s updated new drug application that had been submitted in February of 2024. The FDA indicated then that it required additional information concerning labeling and pre-approval inspection at their third-party manufacturing site.
The inspection took place between June 10th through June 19th of 2024. However, the FDA did not request additional clinical studies and did not question the clinical data.
In April 2025, an updated NDA was submitted addressing all the FDA’s previous concerns. Andersson issued a subsequent press release, stating that the quality review responding to questions by the FDA has proceeded according to plan and the quality requirements have been fulfilled. The Company gave assurances that they are well prepared to launch dasatinib on the US market upon approval later in the year.
According to the prescribing information for dasatinib tablets (Sprycel), the agent is currently indicated for the treatment of patients with newly diagnosed Philadelphia chromosome (Ph)–positive CML in chronic phase; chronic, accelerated, or myeloid or lymphoid blast phase Ph-positive CML with resistance or intolerance to prior therapy, including (Gleevec); and Ph-positive ALL with resistance or intolerance to prior treatment. The agent is also indicated for use in pediatric patients one year or older with Ph-positive CML in chronic phase and newly diagnosed Ph-positive ALL in combination with chemotherapy.
The prescribing information for dasatinib tablets includes warnings for myelosuppression (insufficient production of blood cells) bleeding events, fluid retention, cardiovascular toxicity, pulmonary arterial hypertension, severe dermatologic reactions, and tumor lysis syndrome. Common adverse events associated with the drug in pediatric patients include but are not limited to diarrhea, vomiting, nausea, cough and abdominal pain, headache, rash, fatigue, constipation, edema, infections and hypertension.
