Gazyva: how long were the pivotal tox studies?

“The route of application was IV (9, 13 and 26-weeks duration) and SC (4-week), thus reflecting the clinical route of administration in the pivotal 26-week study.”

“The route of application was IV (9, 13 and 26-weeks duration) and SC (4-week), thus reflecting the clinical route of administration in the pivotal 26-week study. A 37-week treatment free period was included after the 13 week and 26 week IV studies, respectively.”

“Repeat dose toxicology studies of 13-week or 26-week duration with extended recovery periods were conducted using IV administration of obinutuzumab. A separate 4-week study that evaluated subcutaneous (SC) administration was also completed.”