AbbVie/Roche’s venetoclax bags FDA Breakthrough Therapy Designation
pharmafile | January 21, 2016 | News story | Sales and Marketing | AbbVie, Breakthrough Therapy Designation, FDA, Roche, venetoclax
AbbVie and Roche’s cancer drug venetoclax has been granted Breakthrough Therapy Designation by the FDA in combination with rituximab for the treatment of relapsed/refractory chronic lymphocytic leukaemia.
Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein, being developed by AbbVie in partnership with Roche and its subsidiary Genentech. MabThera (rituximab), which can potentially be used in combination with venetoclax, was also developed by Roche, which sells the drug as Rituxan in the US.
Chronic lymphocytic leukaemia (CLL) is the most common form of chronic leukaemia, and develops from white blood cells in the bone marrow. It is estimated that more than 14,000 people will be diagnosed with the condition in the US alone this year.
“This second Breakthrough Therapy Designation for venetoclax granted by the FDA underscores the significant potential of this therapy in treating relapsed/refractory CLL patients, and reflects AbbVie’s commitment to providing breakthrough therapies for cancer patients,” says Michael Severino, executive vice president of research and development and chief scientific officer at AbbVie. “AbbVie will continue harnessing our collective expertise to accelerate efforts to bring new treatment options to patients battling this difficult to treat blood cancer.”
Earlier this month the FDA had accepted the companies’ application for venetoclax as a monotherapy treatment for patients with relapsed/refractory chronic lymphocytic leukaemia, including patients with the 17p deletion genetic mutation. The regulator granted priority review for venetoclax in this indication, having granted Breakthrough Therapy Designation in April 2015.
Joel Levy
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