Synribo, an oncology portfolio product, was originally granted an accelerated approval by the FDA in October 2012. Additional clinical trial data was required to fulfill post marketing requirements set forth by the FDA.
Global Specialty Medicines president and CEO Dr Rob Koremans noted with this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of Synribo, the company believes healthcare providers can be even more confident in the clinical profile of this important medicine.
"This approval reinforces our ongoing commitment to providing SYNRIBO to people living with CML who have failed two or more TKI therapies," Koremans added.
The original approval of Synribo in October 2012 by the FDA was based on an analysis of combined data subsets from two Phase II, open-label, multicenter studies.
Synribo is the first protein synthesis inhibitor for CML. The proteins affected by Synribo are known as Bcr-Abl and Mcl-1, as shown in laboratory studies not involving patients. Synribo, as a protein synthesis inhibitor, is believed to work does not directly depend on Bcr-Abl binding.
Serious adverse reactions in chronic phase patients included bone marrow failure, thrombocytopenia, febrile neutropenia, and infections. Serious adverse reactions in accelerated phase patients included febrile neutropenia, thrombocytopenia, anemia, diarrhea, and infections.