The FDA accepted and granted priority review status to Bristol-Myers Squibb's supplemental biologics license application for Opdivo, or nivolumab, in combination with Yervoy, or ipilimumab, as a treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma, with an action date of April 16, 2018. The application was supported by the results of a late-stage study in which the combination therapy achieved the primary endpoints of improving the objective response rate and overall survival versus use of Sutent, or sunitinib.
An investigational new drug application was filed by Cellectar Biosciences to the FDA for CLR 131, which is intended to treat adolescents and pediatric patients with certain orphan-designated and rare cancers. The proposed early-stage trial will assess the safety and tolerability of the drug candidate.
Johnson & Johnson's Imbruvica, or ibrutinib, was recommended by the National Institute for Health and Care Excellence as a second-line treatment for patients with mantle cell lymphoma. The company agreed to an undisclosed discount off the drug's selling price.
An FDA import alert was issued for Vietnam-based Sustainable Seafood's fresh and frozen raw tuna because of possible contamination with hepatitis A. The alert stemmed from a screening conducted by the agency in May in which the products tested positive for the virus.
The Apex Heart Institute in India was the first facility outside the US to commercially install Corindus Vascular Robotics' CorPath GRx system, a robot-assisted platform designed to facilitate percutaneous coronary interventions. Corindus and the institute plan to partner on the development of a global center of excellence, where interventional cardiologists will be trained on using the system.
Health Care Service and three Blue Cross/Blue Shield entities have issued positive coverage policy decisions for the use of the HeartFlow FFR-CT Analysis software from HeartFlow. The software is intended to facilitate diagnosis and treatment of patients with suspected coronary artery disease.
The use of Intrinsic Therapeutics' Barricaid anular closure device in partial anulus replacement in patients with herniated discs was denied by the FDA's Orthopaedic and Rehabilitation Devices Panel by a 5-8 vote with one abstention. According to the committee, the benefits of the implant were outweighed by its risks, including high rates of migration and breakage.
Preliminary data from two early-stage trials for Servier and Pfizer's chimeric antigen receptor T-cell therapy candidate, UCART19, proved safety and tolerability among pediatric and adult patients with high-risk relapsed or refractory B-cell acute lymphoblastic leukemia participating in the CALM and PALL studies, according to a presentation made at the annual meeting of the American Society of Hematology. Servier gained exclusive global rights for UCART19 from Cellectis in 2015 and is co-developing the treatment with Pfizer.
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