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Home Industry News Roche leukaemia drug receives FDA priority review status

Roche leukaemia drug receives FDA priority review status

4th July 2013

Roche's new chronic lymphocytic leukaemia therapy GA101 has been accepted for priority review by US regulators.

The Food and Drug Administration (FDA) has granted priority review status to the drug based on positive data from the phase III trial CLL11, which showed that GA101 was able to deliver a statistically significant 86 percent reduction in the risk of disease worsening or death compared to chlorambucil alone.

This comes after the compound received breakthrough therapy designation from the FDA earlier this year and underlines the potential benefits it can provide for leukaemia sufferers.

Marketing applications have also been submitted to other regulatory authorities, including the European Medicines Agency in April 2013.

Dr Hal Barron, chief medical officer and head of global product development at Roche, said: "These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame."

This comes after Roche subsidiary Genentech recently agreed a new cancer research alliance with Immunocore.ADNFCR-8000103-ID-801607986-ADNFCR

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