Roche has received European Commission(EC) approval for its anti-PD-L1 cancer immunotherapy Tecentriq (atezolizumab) to treat specific lung and bladder cancers. The green light means that it can be used as monotherapy for people in the EU with previously-treated locally advanced or metastatic non-small cell cancer (NSCLC), or those with metastatic urothelial carcinoma (mUC) who have received a platinum-based chemotherapy or who are ineligible to receive cisplatin chemotherapy.
The US Food and Drug Administration(FDA) has approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Roche/Genentech’s Avastin (bevacizumab) for the treatment of multiple types of cancer, making it the first biosimilar approved in the country for the treatment of cancer.
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that GlaxoSmithKline plc (LSE:GSK) (NYSE:GSK) has exercised its option under a collaboration and license agreement signed in 2014 to exclusively license the right to research, develop, and commercialize Adaptimmune’s NY-ESO SPEAR T-cell therapy program. Further details will be provided in a conference call scheduled for 8:30 AM EDT this morning; dial-in and webcast details are provided below.
Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, today reported positive top-line results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first in class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
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.
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