US regulators will conduct an accelerated review of Roche group Genentech's 'breakthrough' leukaemia drug obinutuzumab.
The US Food and Drug Administration, which awarded the drug 'breakthrough therapy' status back in May, will make a decision on whether to approve obinutuzumab for chronic lymphocytic leukemia (CLL) by December 20 this year, on the back of impressive late-stage clinical data.
The pivotal 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 (median progression-free survival) was more than doubled (23 months versus 10.9 months) when compared to chlorambucil alone.
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.
In a double-pronged attack, the drug also binds to CD20 to kill off cancerous cells directly, the firm said.
Obinutuzumab has also been filed with regulators in Europe, and in the US Genentech has opened an Expanded Access Program to give CLL patients access to the drug while regulatory approval is being sought.