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
23 Mayo 2024 - 4:00PM
Business Wire
- 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
Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a Swedish
pharmaceutical company which uses its innovative Hynap technology
to develop 505(b)(2) improved versions of marketed drugs for the
treatment of cancer announced today the online publication of its
abstract titled “Frequency of Comedication of Proton Pump
Inhibitors with Crystalline Dasatinib in Chronic Myeloid Leukemia
and Effects on TKI-Bioavailability” for presentation at the
upcoming American Society of Clinical Oncology (ASCO) Annual
Meeting in Chicago on June 3rd, 2024 at 9-12 AM, Poster nr. 120
(1).
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 Uppsala University and the
Karolinska Institute and University Hospital demonstrates that 54%
of CML patients identified in the Swedish CML-register were
prescribed at least one PPI and 34% of TKI-treated patients were
comedicated with a PPI. Of those prescribed a PPI, 66% of the
prescriptions were by a different healthcare provider. Further, the
presentation provides new information on the bioavailability of
crystalline dasatinib when comedicated with a PPI, demonstrating a
substantially higher than previously reported impact of PPIs on the
bioavailability of crystalline dasatinib, with Cmax and AUC24 being
reduced by 96% and 88% respectively.
“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 July 2024 and the US commercial launch
of Dasynoc on 1st September 2024.”
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.
Accessed 22 May 2024.
About Xspray Pharma AB
Xspray Pharma AB (publ) is a pharmaceutical company focused on
the development of improved PKIs for cancer treatment, leveraging
its proprietary HyNap™ technology platform. The company aims to
enhance clinical outcomes for cancer patients by improving the
efficacy, safety, and patient experience of existing cancer
therapies. Xspray Pharma’s shares are traded at Nasdaq Stockholm
(Nasdaq Stockholm: XSPRAY). For more information about Xspray
Pharma AB and its innovative approach to cancer treatment, please
visit www.xspraypharma.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20240523850369/en/
Kerstin Hasselgren Senior Advisor & Investor Relations
Xspray Pharma AB Mob: +46 (0) 70 311 16 83 E-mail:
kerstin.hasselgren@xspray.com