Teva Pharmaceutical has received US Food and Drug Administration(FDA)approval for Synribo injection to treat adult patients with chronic phase(CP)or accelerated phase(AP)chronic myeloid leukemia(CML)with resistance and/or intolerance to two or more tyrosine kinase inhibitors(TKIs).
Teva Pharmaceutical Industries Global R&D president and chief scientific officer Michael Hayden said Teva has brought Synribo to the market for patients who need additional treatment options when others have failed.
"SYNRIBO joins TREANDA and TRISENOX as important hematologic treatment options in the Teva Oncology portfolio,"Hayden added.
Synribo has received an accelerated approval,which allows the FDA to approve a drug to treat a serious disease based on clinical data.
The approval is based on combined data subsets from two phase II,open-label,multicenter studies,which included patients administered with 2 or more approved TKIs and had evidence of resistance or intolerance to dasatinib and/or nilotinib.
