FDA grants breakthrough therapy designation to venetoclax

The FDA today granted breakthrough therapy designation to venetoclax for previously treated patients with relapsed or refractory chronic lymphocytic leukemia who harbor the 17p deletion genetic alteration, according to a press release from the drug’s manufacturer.

Roche Chief Medical Officer and Head of Global Clinical Development Sandra Horning said in a statement that they are excited that FDA has granted venetoclax breakthrough therapy designation and they look forward to this regulatory pathway, which according to them will help them bring venetoclax to people with this disease.

Venetoclax is currently under evaluation in phase 2 and phase 3 trials in patients with CLL — including those who harbor the 17p deletion — and other malignancies. Approximately 30% to 50% of patients with relapsed or refractory CLL harbor this genetic alteration, and the median life expectancy for these patients is less than 2 to 3 years, according to the release.