Xspray Advances FDA Reviews of Nilopki and Dasynoc as Key Regulatory Milestones Approach

Xspray Pharma AB has provided an update on the FDA review of its two new drug applications for chronic myeloid leukemia (CML). The company has requested a Type A meeting to discuss its response to the Complete Response Letter (CRL) issued for Nilopki® (nilotinib), while Dasynoc® (dasatinib) has progressed to FDA labeling review, a late-stage step in the NDA process, ahead of its August 25, 2026, PDUFA date.

The FDA has also accepted Xspray’s request for a Type C meeting to discuss a potential labeling enhancement for Dasynoc based on recommendations from an advisory board of international CML specialists.

Reformulated TKIs for Chronic Myeloid Leukemia

Nilopki and Dasynoc are reformulated versions of the established tyrosine kinase inhibitors nilotinib and dasatinib. Xspray’s particle engineering technology improves drug solubility and bioavailability to enhance the consistency of drug exposure in patients requiring long-term CML treatment.

Nilopki CRL Focuses on Manufacturing

According to Xspray, the FDA’s June 4 Complete Response Letter does not question the application’s clinical evidence or stability package. Instead, it primarily focuses on manufacturing and regulatory requirements.

The agency has not yet completed an inspection of the contract manufacturing facility to establish current good manufacturing practice (CGMP) compliance. It also requested clarification on dose correspondence with Tasigna® for a limited patient subgroup and additional information from planned commercial-scale manufacturing batches.

Xspray said it has defined a response strategy and expects to discuss it with the FDA during a Type A meeting within the next 30 days.

Dasynoc Advances Toward FDA Decision

The FDA is currently reviewing Dasynoc’s prescribing information and product labeling. Recent agency comments addressed labeling language, formatting, and design, and the company said it has already submitted the requested revisions.

Since resubmitting the NDA, Xspray has not received additional questions related to product quality. Although NerPharMa recently received a positive inspection outcome from Italy’s AIFA, an FDA inspection of the facility remains pending and is the key regulatory requirement for both applications.

The proposed Type C meeting will allow discussions on a potential labeling enhancement that could further strengthen Dasynoc’s clinical profile if accepted by the FDA.

Regulatory Path Forward

CEO Blake Leitch said discussions with the FDA remain productive and that the remaining regulatory steps for both programs are well defined. He added that contract manufacturer NerPharMa, now owned by Benta Group, recently underwent a positive inspection by the Italian Medicines Agency (AIFA), with an FDA inspection expected to follow.

Xspray now awaits FDA feedback on Nilopki’s Type A meeting request and continues toward Dasynoc’s August 25, 2026, PDUFA date. For both applications, successful completion of the manufacturing inspection remains the final major regulatory milestone before potential approval.

Reference

Xspray Pharma provides regulatory update on its US product candidates Nilopki® and Dasynoc® and notes continued progress with its third-party manufacturer NerPharMa – Xspray