publication date: May. 8, 2015

FDA Grants Breakthrough Designation to Venetoclax


Venetoclax was granted Breakthrough Therapy Designation by the FDA for the treatment of chronic lymphocytic leukemia in previously treated patients with the 17p deletion genetic mutation.

Venetoclax is sponsored by AbbVie, and is being developed in partnership with Genentech and Roche.

Venetoclax is an investigational oral B-cell lymphoma-2 inhibitor being evaluated for the treatment of patients with various cancer types. The BCL-2 protein prevents apoptosis of some cells, including lymphocytes, and can be expressed in some cancer types. Venetoclax is currently being evaluated in phase II and phase III clinical trials for the treatment of CLL, along with studies in several other cancers.


DanDrit Biotech USA Inc. signed a collaboration agreement with GISCAD Foundation, an Italian group focused on cancers of the digestive tract.

The collaboration includes VIVA, a phase III adjuvant trial of DanDrit’s vaccine in patients with no evidence of disease stage IV colorectal cancer.

The primary aim of the trial is to evaluate the ability of MelCancerVac to prevent a relapse in CRC patients rendered disease free after completion of standard treatment according to local practices.


Member companies of the Pharmaceutical Research and Manufacturers of America invested an estimated $51.2 billion last year in the research and development of new innovative treatments and cures. The figure represents the majority of all biopharmaceutical R&D spending, both public and private, in the U.S.

Continue reading 41-18 FDA Grants Breakthrough Designation to Venetoclax

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