With this approval, physicians who treat adults with chronic or accelerated phase CML who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors (TKIs) will now have an option to allow their patients to administer SYNRIBO therapy at home.
The company is working to finalize a comprehensive specialty pharmacy support program which will help facilitate successful home administration of SYNRIBO for HCPs, their patients and caregivers.
This program is expected to go live in the second quarter of 2014.
Teva Oncology vice president and general manager Bill Campbell said as the company continues to expand its oncology portfolio and services, the updated labeling for SYNRIBO shows 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.
Roswell Park Cancer Institute chief of the Leukemia Section Meir Wetzler said it had been necessary for adults living with chronic or accelerated phase CML who are prescribed SYNRIBO to travel to their doctor’s office twice a day for two weeks, which can be extremely burdensome and inconvenient to both patients and their caregivers.
"Now, physicians can decide if their patients are candidates for self administration, and if so, provide their patients with guidance on how to properly administer reconstituted SYNRIBO in the home," Wetzler said.