Another FDA Breakthrough designation for Venclexta

Today, US biopharma major AbbVie (NYSE: ABBV) announced that the US Food and Drug Administration has granted a Breakthrough Therapy designation (BTD) to venetoclax (marketed as Venclexta) for use in combination with obinutuzumab as a fixed duration, first-line chemotherapy-free combination for patients with chronic lymphocytic leukemia (CLL) who have not been previously treated.

Simultaneously, the FDA will also review venetoclax and obinutuzumab under its Real-Time Oncology Review (RTOR) pilot program, to ensure effective options are medicines are available to patients as early as possible.

Venclexta is being jointly commercialized by AbbVie and Genentech, a subsidiary of Swiss pharma giant Roche (ROG: SIX), in the USA and by AbbVie outside of the USA. AbbVie recorded global Venclexta (venetoclax) net revenues of $124 million in the fourth quarter of 2018 and $344 million for the full year.