Entering text into the input field will update the search result below

AbbVie and Roche's venetoclax gets new Breakthrough Therapy tag for blood cancer

Jan. 20, 2016 9:18 AM ETAbbVie Inc. (ABBV) StockRHHBY, ABBVBy: Douglas W. House, SA News Editor
  • 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)

Recommended For You

More Trending News

About ABBV Stock

SymbolLast Price% Chg
Market Cap
PE
Yield (TTM)
Rev Growth (YoY)
Prev. Close
Compare to Peers

Related Stocks

SymbolLast Price% Chg
ABBV--
AbbVie Inc.