
The Blincyto adverse events observed in the TOWER study were consistent with the known safety profile of Blincyto. Secondary endpoints are currently being evaluated. These interim data will be submitted to a future medical conference and for publication.
“The FDA’s breakthrough therapy designation and accelerated approval of Blincyto underscore the dire prognosis for these patients. This is the first study to demonstrate an overall survival benefit for these patients with an immunotherapy, and this is a tremendously rare achievement in relapsed and refractory ALL,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We will work with regulatory authorities towards a full approval for Blincyto in this population.”
Source: Amgen
Filed Under: Drug Discovery