Xspray to present data at ASCO highlighting frequent comedication of PPIs with TKIs in CML-patients and greater than expected negative effects on the bioavailability of crystalline dasatinib
- 54% of TKI-treated CML-patients received a PPI
- 66% of concomitant prescribing was by a different healthcare provider
- Crystalline dasatinib Cmax and AUC24 reduced by 96% and 88% respectively
While Tyrosine Kinase Inhibitors (TKI), including dasatinib, have profoundly improved clinical outcomes in patients with chronic myeloid leukemia (CML), the bioavailability and systematic exposure of the crystalline formulation of dasatinib is reduced by comedication with acid reducing agents which may affect the clinical response and comedication with proton pump inhibitors, such as omeprazole, should be avoided (2).
The collaborative analysis with
“Consistent absorption and bioavailability of dasatinib are critical for adequate disease control and patient outcomes, this is however often overlooked in clinical practice as our data demonstrates,” said Per Andersson, CEO of Xspray. “To address this important issue, we are on track to launch Dasynoc®, our optimized version of dasatinib, with a Prescription Act Use Fee Amendment date (PDUFA-date) of 31st of
The abstract is now available online at https://meetings.asco.org/2024%20ASCO%20Annual%20Meeting/15766?presentation=239588#239588
References:
-
Dahlén T, Larfors G, Lennernäs H et al. Frequency of Comedication of Proton Pump Inhibitors with Crystalline Dasatinib in Chronic Myeloid Leukemia and Effects on TKI-Bioavailability.
American Society of Clinical Oncology , Annual Meeting 2024.Chicago . Abstract 6561. Poster 120. https://meetings.asco.org/2024%20ASCO%20Annual%20Meeting/15766?presentation=239588#239588 -
Sprycel® (dasatinib) Tablets for oral use. Labeling, Supplement 27.
02 Aug 2023 . https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021986. Accessed22 May 2024 .
About
View source version on businesswire.com: https://www.businesswire.com/news/home/20240523850369/en/
Senior Advisor & Investor Relations
Mob: +46 (0) 70 311 16 83
E-mail: kerstin.hasselgren@xspray.com
Source: