According to GlaxoSmithKline, this use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.
"Arranon affirms GSK's long-term commitment to discover drugs for the treatment of cancer and to working with others in the cancer community to develop treatments for even the most difficult to treat malignancies," says Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center, at GSK.
More than 980 patients have received Arranon as part of clinical trial protocols to date. The two multi-center pivotal Phase II clinical trials included a total of 39 adults and 151 children with T-ALL or T-LBL.
In these groups, a total of 21-percent of the adults and 23-percent of the children achieved a complete response or a complete response without full hematological recovery with single agent Arranon. Remissions were generally long enough to allow for stem cell transplant procedure, often the intent following successful induction of remission. Following Arranon, patients had a median overall survival of 21 weeks for adults and 13 weeks for children.
"Arranon represents new hope for adults and children suffering from these rare and deadly cancers," says Kevin Lokay, Vice President of Oncology and Acute Care at GSK. "As the first in a series of innovative medicines set to emerge from GSK's robust oncology pipeline over the next few years, Arranon is an important milestone for our oncology business and provides a glimpse of our promise for the future."
