CRL issued for Dasynoc (dasatinib) in CML and ALL
- Sponsor
- Xspray Pharma AB $XSPRAY
- Drug
- Dasynoc · dasatinib
- Indication
- chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL)
FDA issued a complete response letter to Xspray Pharma's NDA for Dasynoc, a lower-dose bioequivalent formulation of dasatinib for CML and ALL, six days ahead of the Aug 25 PDUFA. The second consecutive CRL cites manufacturing observations at Xspray's contract manufacturer.
What this means
Dasynoc is a reformulated version of the leukemia drug dasatinib, designed to deliver equivalent effect at a 30% lower dose with more consistent absorption in patients who take acid-reducing medications. FDA declined to approve the NDA in its present form, citing manufacturing observations at Xspray's contract manufacturer rather than concerns about the drug itself. This is the second consecutive complete response letter on the Dasynoc program; the first was issued in October 2025 after the original filing and also concerned manufacturing rather than clinical data. Xspray has stated it intends to address the observations and resubmit in 2026.
Drug Watch — recent news on Dasynoc
- FDA Again Rejects Reformulated Dasatinib for CML and ALL Treatment - Targeted Oncology
- FDA Issues Another CRL for Amorphous Dasatinib Receives in CML and ALL - CancerNetwork
- Xspray's Dasynoc approval bid foiled again by FDA's manufacturer concerns - Fierce Pharma
- Dasatinib reversibly disrupts T cell motility and activation in lymph nodes - Science | AAAS
- S1711 Dasatinib-Induced Colitis: A Potential... : American Journal of Gastroenterology - Lippincott Home
Sponsor Watch — recent news on Xspray Pharma AB
- Wall Street's Bull Case for Bristol Myers Squibb Is Getting Louder
- Bristol Myers Squibb to Report Results for Third Quarter 2026 on October 29, 2026
- Bristol-Myers Squibb (BMY), What Is Behind The Fresh Attention?
- Bristol Myers Squibb (BMY) Funds India Lung Cancer Screening Research Beyond Smoking
- Can Sotyktu's Long-Term PsA Data Boost Bristol Myers' Prospects?