Breakthrough GA101 leukaemia drug to undergo speedy FDA review

Posted on 4 Jul 2013 by Tim Brown

Roche group Genentech's 'breakthrough' leukaemia drug obinutuzumab is to undergo an accelerated review by the US Food and Drug Administration following impressive late-stage clinical data.

The Phase III CLL11 trial showed that patients taking obinutuzumab plus the chemotherapy demonstrated a statistically significant 86% reduction in the risk of disease worsening or death.

Also, according to the trial, the length of time during which people lived without their disease worsening was more than doubled (23 months versus 10.9 months) when compared to patients using chlorambucil alone.

According to the Pharmatimes,  the drug, which is also known as GA101, is the first type II anti-CD20 medicine to be glycoengineered, a process by which specific sugar molecules are modified to change the interaction with the body’s immune cells, to help remove cancer cells from the body.