FDA granted Exact Sciences' DNA methylation based liquid biopsy test Breakthrough Device designation for detection of hepatocellular carcinoma, based on recently presented data.
FDA has accepted Bristol-Myers Squibb's supplemental Biologics License Application and granted Breakthrough Therapy Designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib.
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental New Drug Application to FDA seeking approval to expand the Imbruvica (ibrutinib) label to include the combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Health Canada has approved Imbruvica (ibrutinib) in combination with obinutuzumab for treatment-naïve patients with active chronic lymphocytic leukemia.
UroGen Pharma paid $10 million to Agenus Inc. for access to zalifrelimab (AGEN1884, anti-CTLA-4 antibody) for use with sustained release technology for intravesical delivery in patients with urinary tract cancers.
Ashwani Rajput, a cancer surgeon and researcher with an interest in health care disparities, was appointed director of the Kimmel Cancer Center at Johns Hopkins for the Washington, D.C., region.
W. Kimryn Rathmell received the Kidney Cancer Association's Eugene P. Schonfeld Award that recognizes health care professionals who have made significant contributions in the treatment of renal cell carcinoma.
The St. Baldrick's Foundation has awarded 25 infrastructure grants totaling nearly $1.5 million to institutions across the U.S.
Moffitt Cancer Center has formed a collaboration with Bay Pines VA Healthcare System and James A. Haley Veterans' Hospital to expand its clinical research to include veterans being treated at the two Tampa Bay area facilities.
Friends of Cancer Research has published three white papers that focus on the development of external controls, the assessment of combination immuno-oncology therapies for patients with disease progression, and the generation of data for companion diagnostics.
