Swedish pharmaceutical company Xspray Pharma AB (STO:XSPRAY) said on Thursday that the US Food and Drug Administration (FDA) has agreed to review the company's application for market approval for its product candidate Dasynoc (dasatinib).
This application consists of the results from registrational studies on healthy volunteers, where bioequivalence was achieved at an approximately 30% lower dosage than the reference product Sprycel. The application includes Dasynoc for the treatment of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML), which are blood cancer illnesses in an area where only one new drug has been registered over a ten-year period, the company said.
Subject to approval from the FDA, Xspray Pharma estimates that Dasynoc could be launched in the US market in 2023.
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML