Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterized by cycles of remission and relapse.
It is looking unlikely that patients in England and Wales with advanced renal cell carcinoma will be getting routine NHS access to Eisai’s Kisplyx or Eusa Pharma’s Fotivda, after cost regulators issued draft guidelines turning down their use.
In the featured translational article in the August issue of The Journal of Nuclear Medicine, researchers at the University of Michigan demonstrate the potential of a new PET tracer, Carbon-11 labeled sarcosine (11C-sarcosine), for imaging prostate cancer, and set the stage for its possible use in monitoring other cancers.
The European Commission has expanded the scope of Novartis’ Zykadia to include the first line treatment of patients with non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive.
Owlstone Medical and Cancer Research UK (CRUK) have begun a clinical trial designed to identify biomarkers of cancer in breath samples. The goal is to find volatile organic compounds (VOCs) that indicate the presence of cancer, enabling physicians to make quick, noninvasive diagnoses.
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