Dasynoc FDA Approval Status

Last updated by Judith Stewart, BPharm on Aug 12, 2024.

FDA Approved: No
Brand name: Dasynoc
Generic name: dasatinib
Previous Name: XS004
Company: Xspray Pharma AB
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia

Dasynoc (dasatinib) is an optimized version of the approved kinase inhibitor dasatinib in development for the treatment of chronic myeloid leukemia and acute lymphoblastic leukemia.

Chronic myeloid leukemia (CML) is a type of blood cancer where the body produces malignant white blood cells. Acute lymphoblastic leukemia (ALL) is an acute form of blood cancer caused by rapid growth of immature lymphocytes (lymphoblasts) in the bone marrow due to various genetic changes. Almost all patients with CML and about 25 percent of patients with ALL have an abnormality known as the "Philadelphia chromosome," which produces an abnormal protein called BCR-ABL.
Dasynoc contains dasatinib, a kinase inhibitor that works by inhibiting BCR-ABL which causes the bone marrow to produce too many immature or damaged white blood cells.
Dasatinib was first approved under the brand name Sprycel in 2006 and is used for the treatment of Philadelphia chromosome-positive (Ph+) CML and ALL.
Studies have confirmed that Dasynoc:
- has achieved bioequivalence with a 30 percent lower dose compared to the original drug, Sprycel.
- is unaffected by the pH value of the stomach and can thus be used together with omeprazole without affecting the absorption of dasatinib, which facilitates treatment of peptic ulcers while the patient is being treated for cancer
- yields a more even and consistent uptake of dasatinib in the body without those cases of low uptake that are linked to the reference product.
- can be administered at a lower dosage than the reference product, which is expected to yield fewer side effects.

Development timeline for Dasynoc

Date	Article
Jul 26, 2024	Xspray Pharma Shares New Information on Dasynoc, a Novel CML Treatment in Development
Feb 12, 2024	FDA Accepts Xspray Pharma’s NDA-Resubmission for Dasynoc
Jul 11, 2023	Xspray Pharma Receives Request for Additional Information Concerning Dasynoc from FDA
Nov 30, 2022	Xspray Pharma’s Drug Candidate XS004 Granted Orphan Drug Designation in the US for the Treatment of Acute Lymphoblastic Leukemia
Jun 17, 2022	Dasynoc Granted Orphan Drug Designation in the US for the Treatment of Chronic Myeloid Leukemia

Further information

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