Sixth Breakthrough Therapy designation for Roche and AbbVie drug

Venclexta (venetoclax), in combination with azacytidine, has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA) for previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International prognostic scoring system (IPSS-R).

Also known as Venclexto, the drug from Roche (ROG: SIX) and AbbVie (NYSE: ABBV) has now been granted BTD six times, demonstrating its potential across multiple blood cancers.

The other designations have come in previously untreated chronic lymphocytic leukaemia (CLL), two in relapsed or refractory CLL, two in previously untreated acute myeloid leukemia, and one in myelodysplastic syndromes. Regulatory approval has been granted by the US Food and Drug Administration in three indications.