FDA grants advanced therapy designation for venetoclax

According to Swiss drugmaker Roche, the US Food and Drug Administration (FDA) has granted advanced therapy designation for venetoclax for treating people who have relapsed or refractory chronic lymphocytic leukemia with a genetic abnormality.

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.

Michael Severino, MD, executive vice-president of research and development and chief scientific officer of AbbVie, said in a press release, "The Breakthrough Therapy Designation of venetoclax supports the continued development of this investigational medicine in CLL patients with 17p deletion. The continuing advancement of the venetoclax development program is one example of AbbVie's focus on delivering innovative medicines that address unmet clinical needs".

Venetoclax (AbbVie and Genentech/Roche) is designed to inhibit the function of the BCL-2 protein selectively. According to a press release, the BCL-2 protein helps prevent apoptosis of some cells, together with lymphocytes; it can also be expressed in other cancer types.

At present, Venetoclax is being evaluated in phase-2 and phase-3 trials in patients with CLL, together with those who harbor the 17p deletion, and other malignancies.

As per the FDA, Breakthrough Therapy Designation is aimed at accelerating the development and review of drugs for life-threatening conditions. Breakthrough Therapy Designation criteria consists of preliminary clinical evidence showing that a drug could have considerable improvement on at least one clinically significant final stage of the process compared to available therapy.