AbbVie and Genentech receive breakthrough designation for venetoclax

AbbVie and Genentech have been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for their investigational medicine venetoclax.

The BCL-2 protein inhibitor is designed for the treatment of chronic lymphocytic leukaemia (CLL) in previously treated relapsed or refractory patients with the 17p deletion genetic mutation – a variation found in approximately three to ten percent of all CLL patients.

Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions, meaning the companies will now benefit from an accelerated evaluation process.

AbbVie plans to file for approval of the drug with the FDA and the European Medicines Agency before the end of the year.

Dr Michael Severino, executive vice-president of research and development and chief scientific officer at AbbVie, said: "The continuing advancement of the venetoclax development programme is one example of AbbVie's focus on delivering innovative medicines that address unmet clinical needs."