Teva Pharmaceutical has obtained US Food and Drug Administration (FDA) approval for Synribo (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration for patients with chronic or accelerated phase chronic myeloid leukaemia (CML).
Along with the new indication for omacetaxine mepesuccinate, the FDA also approved a related medication guide and instructions for use.
A protein synthesis inhibitor, Synribo is a prescription medicine used to treat adults with chronic or accelerated phase chronic myeloid leukaemia (CML) who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors (TKIs).
With this approval, physicians who treat adults with chronic or accelerated phase CML will now have the option to allow their patients to administer Synribo therapy at home.
Teva is currently in the process of finalising a comprehensive specialty pharmacy support programme that will help facilitate successful home administration of Synribo for healthcare professionals, their patients and caregivers.
Teva expects to launch the comprehensive specialty pharmacy support programme in the second quarter of 2014.
Teva Oncology vice-president and general manager Bill Campbell said that as the company continues to expand its oncology portfolio and services at the company, the updated labelling for Synribo demonstrates its commitment to improving the overall experience and lowering barriers to treatment for people living with CML.
"Home administration can reduce the number of required doctor office visits for patients being treated with Synribo, while still maintaining close collaboration with their healthcare provider to manage their treatment regimen," Campbell said.
The FDA originally granted an accelerated approval for Synribo in October 2012.
Based on the submission of 24 month update to the safety and efficacy data, the FDA had granted a full approval in February 2014.
The proteins affected by Synribo are known as Bcr-Abl and Mcl-1. These are examples of some of the proteins that are produced in higher levels by cancerous CML cells and help drive the disease.
As a protein synthesis inhibitor, the way Synribo is believed to work does not directly depend on Bcr-Abl binding.
Serious adverse reactions with Synribo in chronic phase patients include bone marrow failure, thrombocytopenia, febrile neutropenia, and infections.
Serious adverse reactions with Synribo in accelerated phase patients include febrile neutropenia, thrombocytopenia, anaemia, diarrhoea, and infections.
Most common adverse reactions with Synribo in chronic and accelerated phase patients include thrombocytopenia, anaemia, neutropenia, diarrhoea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, and lymphopenia.
Image: Bone marrow aspirate showing acute myeloid leukemia. Photo: courtesy of ToNToNi.