The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix (panitumumab) to include combination with FOLFIRI as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer.
FDA granted Breakthrough Therapy Designation to EBV-CTL for the treatment of Epstein-Barr Virus following transplant of bone marrow stem cells.
FDA granted accelerated approval to Farydak (panobinostat) for the treatment of multiple myeloma. The FDA had previously granted Farydak priority review and an orphan product designation.
The FDA issued a safety alert regarding the design of endoscopic retrograde cholangiopancreatography duodenoscopes, and how it may impede effective cleaning of the reusable device.
Bristol-Myers Squibb Company and Rigel Pharmaceuticals Inc. entered into a collaboration for the discovery, development and commercialization of cancer immunotherapies based on Rigel's portfolio of small molecule TGF beta receptor kinase inhibitors.
FDA granted Rintega (rindopepimut) a Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma.
FDA granted accelerated approval to Ibrance (palbociclib) to treat metastatic breast cancer.
FDA approved Lenvima (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvima was approved following a priority review.
The U.K. National Health Service established an access program for the Oncotype DX test, developed by Genomic Health Inc., for breast cancer patients, effective April 1.
FDA granted an Orphan Drug Designation to Reolysin for the treatment of pancreatic cancer.
