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Roche nabs two positive Ad Comm opinions in Europe for expanded uses of Avastin and Gazyvaro

Apr. 29, 2016 12:35 PM ETRoche Holding AG (RHHBY) StockBIIB, RHHBYBy: Douglas W. House, SA News Editor
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions recommending approval of new indications for Roche's (OTCQX:RHHBY -0.4%) Gazyvaro (obinutuzumab) and Avastin (bevacizumab).
  • The thumbs up for Gazyvaro is the treatment of follicular lymphoma, in combination with bendamustine chemo, followed by maintenance therapy with Gazyvaro in patients who failed to respond to or progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen, an indication already approved in the U.S.
  • CHMP's positive recommendation was based on results from the Phase 3 GADOLIN study which showed treatment with Gazyvaro reduced the risk of cancer worsening or death by 52%.
  • Gayzvaro/Gazyva, a CD20-directed monoclonal antibody, is currently approved for the treatment of chronic lymphocytic leukemia.
  • The thumbs up for Avastin is the first-line treatment, in combination with Tarceva (erlotinib), of adults with EGFR-positive, unresectable, advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). A mid-stage study, JO25567, showed treatment with Avastin extended progression-free survival by a median of 6.3 months. Avastin is currently approved for a range of cancers, including non-squamous NSCLC (in combination with carboplatin and paclitaxel).
  • Final decisions by the European Commission usually take ~60 days.
  • Related ticker: (BIIB -2.5%)

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