The European Commission has approved Switzerland-based Novartis' Tasigna intended to treat paediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemic in the chronic phase (Ph+ CML-CP), it was reported yesterday.
The product has also been approved for the treatment of paediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib. It is said to be the only second-generation tyrosine kinase inhibitor presently approved in the European Union.
The approval was based on two prospective studies of nilotinib in children with Ph+ CML-CP, which were part of a formal paediatric investigation plan agreed upon with the EMA.
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
Ligand Pharmaceuticals announces presentation of Captisol-enabled Topiramate Injection data