- The FDA designates venetoclax, in combination with RITUXAN (rituximab), a Breakthrough Therapy for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL).
- Venetoclax, an inhibitor of a protein called B-cell lymphoma-2, is being co-developed by AbbVie (NYSE:ABBV) and Roche (OTCQX:RHHBY). It is also tagged a Breakthrough Therapy for Priority Review as a single agent for the treatment of CLL in relapsed/refractory patients with a genetic mutation known as a 17p deletion, the marketing applications for which are currently under review in the U.S. and Europe.
- Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- Previously: FDA grants Priority Review for AbbVie's venetoclax NDA (Jan. 12)